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Miscellaneous
QGN
Lateral Flow Immunochromatography Assay For Host Infection Biomarkers
2
Product Code
PBK
Non-Variola Orthopoxvirus Real-Time Pcr Primer And Probe Set
2
Product Code
OBF
Assay, Genotyping, Hepatitis C Virus
3
Product Code
PGH
Hsv-1 And Hsv-2 Cns Nucleic-Acid Based Panel
2
Product Code
QHM
Serology Tests Used For Infectious Disease Screening Of Blood And Plasma Donations
U
Product Code
PQA
Vaginitis And Bacterial Vaginosis Nucleic Acid Detection System
2
Product Code
PRA
Variola Virus Nucleic Acid-Based Detection Assay
2
Product Code
PRH
Positive Blood Culture Identification And Ast Kit
2
Product Code
PVQ
Rickettsia Spp. Nucleic Acid Based Detection Assay
2
Product Code
PYN
Fish (Fluorescence In Situ Hybridization) Kit, Nucleic Acid, Plasmodium Sp.
2
Product Code
QAA
Coccidioides Spp. Nucleic Acid Detection System For Respiratory Specimens
2
Product Code
QBD
Microbial Nucleic Acid Storage And Stabilization Device
2
Product Code
QBN
Mass Spectrometry, Maldi Tof, Microorganism Identification, Cultured Isolates
2
Product Code
QDZ
Qualitative Cytomegalovirus Nucleic Acid-Based Detection Device For Congenital Cytomegalovirus Infection
2
Product Code
QEP
Nucleic Acid Detection System For Non-Viral Microorganism(S) Causing Sexually Transmitted Infections
2
Product Code
QFA
Assay For Detection Of Proteases In Chronic Wounds
2
Product Code
QFO
Zika Virus Serological Reagents
2
Product Code
QHO
Nucleic-Acid Tests Used For Infectious Disease Screening Of Blood And Plasma Donations
U
Product Code
QID
Device To Detect Antigens Of Biothreat Microbial Agents In Human Clinical Specimens
2
Product Code
QNJ
Mass Spectrometry, Microorganism Identification, Blood Culture
2
Product Code
MZP
Assay, Hybridization And/Or Nucleic Acid Amplification For Detection Of Hepatitis C Rna,Hepatitis C Virus
3
Product Code
NCD
Test, Immunity, Cell Mediated, Mycobacterium Tuberculosis
3
Product Code
NWY
Test, Qualitative, Detection Of Dengue Igm And Igg Antibodies
N
Product Code
QPO
Device To Preserve And Stabilize Relative Abundances Of Microbial Nucleic Acids In Clinical Samples
2
Product Code
QQV
Automated System For Sample Preparation And Identification Of Microorganisms From Cultured Isolates By Mass Spectrometry
2
Product Code
PZF
Mers-Cov And Common Respiratory Pathogens Multiplex Nucleic Acid Detection System
2
Product Code
QDS
Mers-Cov And Common Respiratory Pathogens Semi-Quantitative And Quantitative Multiplex Nucleic Acid Detection System
2
Product Code
LOM
Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)
3
Product Code
P
21
0003
ARCHITECT HBsAg Next Qualitative Reagent Kit, ARCHITECT HBsAg Next Confirmatory Reagent Kit, ARCHITECT HBsAg NEXT Qualit
APPR
PMA Approval
P
21
0019
ADVIA Centaur Anti-HBc Total (HBcT2) and Atellica IM Anti-HBc Total (HBcT2)
APPR
PMA Approval
P
20
0017
ADVIA Centaur Anti-HBe2 (aHBe2) assay
APPR
PMA Approval
P
19
0034
Elecsys Anti-HBs II, PreciControl Anti-HBs, Anti-HBs CalCheck
APPR
PMA Approval
P
19
0005
Elecsys Anti-HBe, PreciControl Anti-HBe
APPR
PMA Approval
P
19
0017
LIAISON® XL MUREX HBsAg Qual, LIAISON® MUREX Control HBsAg, and LIAISON® XL MUREX HBsAg Confirmatory Test
APPR
PMA Approval
P
18
0049
LIAISON® XL MUREX anti-HBe, LIAISON® XL MUREX Control anti-HBe
APPR
PMA Approval
P
18
0048
LIAISON® XL MUREX HBeAg, LIAISON® XL MUREX Control HBeAg
APPR
PMA Approval
P
18
0045
LIAISON® XL MUREX HBc IgM, LIAISON® XL MUREX Control HBc IgM
APPR
PMA Approval
P
18
0039
LIAISON® XL MUREX Anti-HBs, LIAISON® XL MUREX Control Anti-HBs and LIAISON® XL MUREX Anti-HBs Verifiers
APPR
PMA Approval
P
18
0045
LIAISON® XL Murex HBc IgM and LIAISON® XL Murex Control HBc IgM
3
PMA Approval
P
18
0039
LIAISON® XL Murex Anti-HBs, LIAISON® XL Murex Control Anti-HBs and LIAISON® XL Murex Anti-HBs Verifiers
3
PMA Approval
P
18
0038
LIAISON® XL Murex Anti-HBc and LIAISON® XL Murex Control Anti-HBc
3
PMA Approval
P
18
0049
LIAISON® XL Murex Anti-HBe and LIAISON® XL Murex Control Anti-HBe
3
PMA Approval
P
18
0048
LIAISON® XL Murex HBeAg and LIAISON® XL Murex Control HBeAg
3
PMA Approval
P
99
0042
ETI-AB-AUK PLUS assay
3
PMA Approval
P
18
0039
LIAISON® XL Murex Anti-HBs, LIAISON® XL Murex Control Anti-HBs and LIAISON® XL Murex Anti-HBs Verifiers
3
PMA Approval
P
99
0043
ETI-EBK PLUS assay
3
PMA Approval
P
99
0038
ETI-MAK-2 PLUS and HBsAg Confirmatory Test assay
3
PMA Approval
P
18
0049
LIAISON® XL MUREX Anti-HBe and LIAISON® XL MUREX Control Anti-HBe
3
PMA Approval
P
18
0045
LIAISON® XL MUREX HBc IgM and LIAISON® XL MUREX Control HBc IgM
3
PMA Approval
P
18
0038
LIAISON® XL Murex Anti-HBc and LIAISON® XL Murex Control Anti-HBc
3
PMA Approval
P
18
0048
LIAISON® XL MUREX HBeAg and LIAISON® XL MUREX Control HBeAg
3
PMA Approval
P
18
0039
LIAISON® XL MUREX Anti-HBs, LIAISON® XL MUREX Control Anti-HBs and LIAISON® XL Murex Anti-HBs Verifiers
3
PMA Approval
P
18
0045
LIAISON® XL MUREX HBc IgM and LIAISON® XL MUREX Control HBc IgM
3
PMA Approval
P
18
0038
LIAISON® XL MUREX anti-HBc and LIAISON® XL MUREX Control anti-HBc
3
PMA Approval
P
18
0048
LIAISON® XL MUREX HBeAg and LIAISON® XL MUREX Control HBeAg
3
PMA Approval
P
18
0049
LIAISON® XL MUREX Anti-HBe and LIAISON® XL MUREX Control Anti-HBe
3
PMA Approval
P
19
0034
Elecsys Anti-HBs II
3
PMA Approval
P
16
0019
Elecsys HBsAg II
3
PMA Approval
P
01
0054
Elecsys Anti-HBs
3
PMA Approval
P
06
0035
ARCHITECT CORE-M / Alinity i Anti-HBc IgM
3
PMA Approval
P
08
0023
ARCHITECT CORE / Alinity i Anti-HBc
3
PMA Approval
P
11
0029
ARCHITECT HBsAg Qualitative/Confirmatory / Alinity i HBsAg Qualitative II/Confirmatory
3
PMA Approval
P
05
0051
ARCHITECT AUSAB / Alinity i Anti-HBs
3
PMA Approval
P
16
0019
Elecsys HBsAg Confirmatory Test
3
PMA Approval
P
05
0051
ARCHITECT AUSAB (LN 1L82)
3
PMA Approval
P
06
0035
ARCHITECT CORE-M (LN 6L23)
3
PMA Approval
P
11
0029
ARCHITECT HBsAg Qualitative (LN 4P53), ARCHITECT HBsAg Qualitative Confirmatory (LN 4P54)
3
PMA Approval
P
08
0023
ARCHITECT CORE (LN 6L22)
3
PMA Approval
P
19
0005
Elecsys Anti-HBe, PreciControl Anti-HBe
3
PMA Approval
P
05
0051
Abbott ARCHITECT AUSAB Reagent (100 Test), Abbott ARCHITECT AUSAB Reagent (500 Test), Abbott ARCHITECT AUSAB Reagent, Al
3
PMA Approval
P
18
0039
LIAISON XL MUREX Anti-HBs, LIAISON XL MUREX Control Anti-HBs and LIAISON XL MUREX Anti-HBs Verifiers
3
PMA Approval
P
19
0017
LIAISON XL MUREX HBsAg Qual, LIAISON XL MUREX Control HBsAg Qual
3
PMA Approval
P
18
0048
LIAISON XL MUREX HBeAg, LIAISON XL MUREX Control HBeAg
3
PMA Approval
P
18
0049
LIAISON XL MUREX Anti-HBe, LIAISON XL MUREX Control Anti-HBe
3
PMA Approval
P
18
0038
LIAISON XL MUREX Anti-HBc, LIAISON XL MUREX Control Anti-HBc
3
PMA Approval
P
18
0045
LIAISON XL MUREX HBc IgM, LIAISON XL MUREX Control HBc IgM
3
PMA Approval
P
20
0017
ADVIA Centaur Anti-HBe2 (aHBe2) assay
3
PMA Approval
P
01
0050
IMMULITE 2000 HBs Ag Confirmatory
3
PMA Approval
P
06
0035
ARCHITECT CORE-M Reagent Kit, Alinity i Anti-HBc IgM Reagent Kit
3
PMA Approval
P
03
0040
Atellica IM Hepatitis B core IgM (aHBcM) Assay
3
PMA Approval
P
04
0004
Atellica IM Anti-Hepatitis B core Total (HBcT) Assay
3
PMA Approval
P
09
0024
Atellica IM Hepatitis B e Antigen (HBeAg) Assay
3
PMA Approval
P
10
0039
Atellica IM Anti-Hepatitis B surface Antigen 2 (aHBs2) Assay
3
PMA Approval
P
11
0041
Atellica IM Hepatitis B surface Antigen II (HBsll), Atellica IM Hepatitis B surface Antigen 11 Confirmatory (HBsll Conf)
3
PMA Approval
P
05
0051
ARCHITECT AUSAB Reagent, ARCHITECT AUSAB Reagent Kit, Alinity i Anti-HBs Reagent Kit
3
PMA Approval
P
08
0023
ARCHITECT CORE Reagent Kit, Alinity i Anti-HBc Reagent Kit
3
PMA Approval
P
11
0029
ARCHITECT HBsAg Qualitative Reagent, ARCHITECT HBsAg Qualitative Confirmatory Reagent, Alinity i HBsAg Qualitative II Re
3
PMA Approval
P
06
0035
ARCHITECT CORE-M Reagent Kit, Alinity i Anti-HBc IgM Reagent Kit
3
PMA Approval
P
10
0039
ADVIA Centaur aHBs2 Assay
3
PMA Approval
P
03
0049
ADVIA Centaur HBsAg ReadyPack Reagents/ADVIA Centaur HBsAg Confirmatory ReadyPack Reagents, ADVIA Centaur HBsAg Quality
3
PMA Approval
P
11
0041
ADVIA Centaur HBsAg II(HBsII), ADVIA Centaur HBsAg Confirmatory, ADVIA Centaur HBsAg Quality Control Material, Atellica
3
PMA Approval
P
04
0004
ADVIA Centaur HBc Total ReadyPack Reagents, ADVIA Centaur HBc Total Quality Control Materials, Atellica IM Anti-Hepatiti
3
PMA Approval
P
01
0051
IMMULITE 2000/2000 XPi Anti-HBc
3
PMA Approval
P
10
0039
ADVIA Centaur anti-HBs2 (aHBs2), ADVIA Centaur Anti-HBs2 (aHBs2) Quality Control Material, Atellica IM Anti-Hepatitis B
3
PMA Approval
P
03
0040
ADVIA Centaur Hepatitis B Core Antigen (aHBcM) Assay, Atellica IM Hepatitis B Core Antigen (aHBcM) Assay, Atellica IM He
3
PMA Approval
P
01
0053
IMMULITE 2000/2000 XPi Anti-HBc IgM
3
PMA Approval
P
19
0034
Elecsys Anti-HBs II, PreciControl Anti-HBs, Anti-HBs CalCheck
3
PMA Approval
P
19
0005
Elecsys Anti-HBe, PreciControl Anti-HBe
3
PMA Approval
P
05
0051
ARCHITECT AUSAB and Alinity i Anti-HBs
3
PMA Approval
P
00
0014
VITROS Immunodiagnostic Products Anti-HBs Quantitative Reagent Pack and Calibrator
3
PMA Approval
P
16
0019
Elecsys HBsAg II Auto Confirm
3
PMA Approval
P
01
0053
IMMULITE 2000 Anti-HBcM
3
PMA Approval
P
01
0051
IMMULITE 2000 Anti-HBc
3
PMA Approval
P
01
0050
IMMULITE 2000 HBsAg Confirmatory
3
PMA Approval
P
01
0052
IMMULITE 2000 Anti-HBs
3
PMA Approval
P
19
0017
LIAISON® XL MUREX HBsAg Qual, LIAISON® MUREX Control HBsAg, and LIAISON® XL MUREX HBsAg Confirmatory Test
3
PMA Approval
P
18
0049
LIAISON® XL MUREX anti-HBe, LIAISON® XL MUREX Control anti-HBe
3
PMA Approval
P
18
0048
LIAISON® XL MUREX HBeAg, LIAISON® XL MUREX Control HBeAg
3
PMA Approval
P
18
0045
LIAISON® XL MUREX HBc IgM, LIAISON® XL MUREX Control HBc IgM
3
PMA Approval
P
11
0041
ADVIA Centaur HBsAgII/Confirmatory Readypack Reagents and QC Material
3
PMA Approval
P
03
0049
ADVIA Centaur HBsAg/Confirmatory Readypack Reagents, Calibrators and Controls
3
PMA Approval
P
10
0039
ADVIA Centaur aHBs2 Readypack Reagents and Quality Control Materials
3
PMA Approval
P
04
0004
ADVIA Centaur HBc Total Readypack Reagents and Quality COntrol Materials
3
PMA Approval
P
03
0040
ADVIA Centaur HBc IgM Readypack Reagents and Quality Control Material
3
PMA Approval
P
09
0024
ADVIA Centaur HBeAg Readypack Reagents and Quality Control Material
3
PMA Approval
P
99
0043
ETI-EBK PLUS assay
3
PMA Approval
P
99
0042
ETI-AB-AUK PLUS assay
3
PMA Approval
P
18
0038
LIAISON XL Murex Anti-HBc and LIAISON XL Murex Control Anti-HBc
3
PMA Approval
P
99
0038
ETI-MAK-2 PLUS and HBsAg Confirmatory Test assays
3
PMA Approval
P
18
0039
LIAISON XL Murex Anti-HBs, LIAISON XL Murex Control Anti-HBs and LIAISON XL Murex Anti-HBs Verifiers
3
PMA Approval
P
18
0038
LIAISON XL MUREX Anti-HBc
3
PMA Approval
P
18
0039
LIAISON XL MUREX Anti-HBs
3
PMA Approval
P
11
0029
ARCHITECT HBsAg Qualitative Reagent Kit, ARCHITECT HBsAg Qualitative Reagent Kit, ARCHITECT HBsAg Qualitative Confirmato
3
PMA Approval
P
05
0051
Alinity i Anti-HBs Reagent Kit
3
PMA Approval
P
06
0035
Alinity i Anti-HBc IgM Reagent Kit
3
PMA Approval
P
08
0023
Alinity i Anti-HBc Reagent Kit
3
PMA Approval
P
11
0029
Alinity i HBsAg Qualitative II Reagent Kit and Alinity i HBsAg Qualitative II Confirmatory Kit
3
PMA Approval
P
11
0029
Alinity i HBsAg Qualitative II
3
PMA Approval
P
05
0051
ARCHITECT AUSAB
3
PMA Approval
P
11
0029
ARCHITECT HBsAg Qualitative/Confirmatory
3
PMA Approval
P
06
0035
ARCHITECT CORE-M
3
PMA Approval
P
08
0023
ARCHITECT CORE
3
PMA Approval
P
08
0023
Alinity i Anti-HBc
3
PMA Approval
P
05
0051
Alinity i Anti-HBs
3
PMA Approval
P
06
0035
Alinity i Anti-HBc lgM
3
PMA Approval
P
18
0038
LIAISON XL MUREX anti-HBc
3
PMA Approval
P
03
0040
Atellica IM Hepatitis B core IgM (aHBcM) Assay
3
PMA Approval
P
04
0004
Atellica IM Anti-Hepatitis B core Total (HBcT) Assay
3
PMA Approval
P
09
0024
Atellica IM Hepatitis B e Antigen (HBeAg) Assay
3
PMA Approval
P
10
0039
Atellica IM Anti-Hepatitis B surface Antigen 2 (aHBs2)Assay
3
PMA Approval
P
11
0041
Atellica IM Hepatitis B surface Antigen II (HBs11) and Atellica IM Hepatitis B surface Antigen 11 confirmatory (HBs11 Co
3
PMA Approval
P
11
0041
ADVIA Centaur and Atellica IM HBsAgII
3
PMA Approval
P
09
0024
ADVIA Centaur and Atellica IM HBeAg
3
PMA Approval
P
03
0049
ADVIA Centaur HBsAg
3
PMA Approval
P
04
0004
ADVIA Centaur and Atellica IM HBc Total
3
PMA Approval
P
10
0039
ADVIA Centaur and Atellica IM Anti-HBs2 (aHBs2)
3
PMA Approval
P
03
0040
ADVIA Centaur and Atellica IM HBc IgM
3
PMA Approval
P
16
0019
Elecsys HBsAg II, Elecsys HBsAg Confirmatory Test, and PreciControl HBsAg II
3
PMA Approval
P
18
0039
LIAISON® XL MUREX Anti-HBs, LIAISON® XL MUREX Control Anti-HBs and LIAISON® XL MUREX Anti-HBs Verifiers
3
PMA Approval
P
11
0029
Alinity i HBsAg Qualitative II, Alinity i HBsAg Qualitative Confirmatory
3
PMA Approval
P
18
0038
LIAISON XL MUREX Anti-HBc, LIAISON MUREX Control Anti-HBc
3
PMA Approval
P
01
0050
IMMULITE 2000 HBsAg & HBs Ag Confirmatory
3
PMA Approval
P
01
0052
IMMULITE 2000 Anti-HBs
3
PMA Approval
P
01
0051
IMMULITE 2000 Anti-HBc
3
PMA Approval
P
01
0053
IMMULITE 2000 Anti HBc IgM
3
PMA Approval
P
05
0051
ARCHITECT AUSAB, LN 1L82
3
PMA Approval
P
03
0049
ADVIA Centaur HBsAg
3
PMA Approval
P
99
0038
ETI MAK-2 PLUS Assay and HBsAg Confirmatory Test
3
PMA Approval
P
99
0042
ETI-AB-AUK PLUS assay
3
PMA Approval
P
99
0043
ETI-EBK PLUS Aassay
3
PMA Approval
P
99
0043
ETI-EBK Plus Assay
3
PMA Approval
P
99
0042
ETI-AB-AUK Plus Assay
3
PMA Approval
P
99
0038
ETI-MAK-2 Plus Assay
3
PMA Approval
P
05
0051
ARCHITECT AUSAB
3
PMA Approval
P
06
0035
Alinity i Anti-HBc IgM Reagent Kit, Alinity i Anti-HBc IgM Calibrators, Alinity i Anti-HBc IgM Controls
3
PMA Approval
P
10
0001
VITROS Anti-HBe
3
PMA Approval
P
00
0044
VITROS HBsAg
3
PMA Approval
P
09
0028
VITROS HBeAg
3
PMA Approval
P
03
0026
VITROS Anti-HBc IgM
3
PMA Approval
P
03
0024
VITROS Anti-HBc
3
PMA Approval
P
00
0014
VITROS Anti-HBs
3
PMA Approval
P
10
0032
Elecsys Anti-HBc II
3
PMA Approval
P
11
0025
Elecsys Anti-HBc IgM
3
PMA Approval
P
11
0031
Elecsys Anti-HBc IgM
3
PMA Approval
P
01
0054
Elecsys Anti-HBs
3
PMA Approval
P
11
0022
Elecsys Anti-HBc IgM
3
PMA Approval
P
10
0031
Elecsys Anti-HBc II
3
PMA Approval
P
99
0012
Elecsys HBsAg Immunoassay
3
PMA Approval
P
16
0019
Elecsys HBsAg II
3
PMA Approval
P
01
0054
Elecsys Anti-HBs; PreciControl Anti-HBs; Anti-HBs CalCheck
3
PMA Approval
P
11
0041
Atellica IM Hepatitis B surface Antigen II (HBsII( and Atellica IM Hepatitis B surface Antigen 1 1 Comfirmatory *HBs11 C
3
PMA Approval
P
09
0024
Atellica IM Hepatitis B e Antigen (HBeAg) Assay
3
PMA Approval
P
04
0004
Atellica Im Anti-Hepatitis B core Total (HBcT) Assay
3
PMA Approval
P
03
0040
Atellica IM Hepatitis B orfe IgM (aHBcM) Assay
3
PMA Approval
P
10
0039
Atellica IM Anti-Hepatitis B surface Antigen 2 (aHBs2) Assay
3
PMA Approval
P
08
0023
Alinity i Anti-HBc Reagent Kit, Alinity i Anti-HBc Calibrator, Alinity i Anti-HBc Controls
3
PMA Approval
P
05
0051
Alinity i Anti-HBs Regent Kit, Alinity i Anti-HBs Calibrators, and Alinity i Anti-HBs Controls
3
PMA Approval
P
03
0026
VITROS Immunodiagnostic Products Anti-HBc IgM Reagent Pack and Calibrator
3
PMA Approval
P
03
0024
VITROS Immunodiagnostic Products Anti-HBc Reagent Pack and Calibrator
3
PMA Approval
P
00
0044
VITROS Immunodiagnostic Products HBsAg Reagent Pack, Calibrator and Confirmatory Kit
3
PMA Approval
P
00
0014
VITROS Immunodiagnostic Products Anti-HBs Quantitative Reagent Pack and Calibrator
3
PMA Approval
P
10
0001
VITROS Immunodiagnostic Products Anti-HBe Reagent Pack and Calibrator
3
PMA Approval
P
09
0028
VITROS Immunodiagnostic Products HBeAg Reagent Pack and Calibrator
3
PMA Approval
P
06
0035
ARCHITECT CORE-M (LN 6l23), Calibrators, Controls and Reagent Kit
3
PMA Approval
P
11
0029
ARCHITECT HBsAg Qualitative (LN 4P53) and HBsAg Qualitative Confirmatory (LN 4P54)
3
PMA Approval
P
05
0051
ARCHITECT AUSAB (LN 1L82)
3
PMA Approval
P
08
0023
ARCHITECT CORE (LN 6L22)
3
PMA Approval
P
10
0032
Elecsys Anti-HBc II
3
PMA Approval
P
11
0022
Elecsys Anti-HBc IgM
3
PMA Approval
P
13
0015
Elecsys HBeAg
3
PMA Approval
P
11
0025
Elecsys Anti-HBc IgM
3
PMA Approval
P
11
0031
Elecsys Anti-HBc IgM
3
PMA Approval
P
16
0019
Elecsys HBsAg II (100/200 tests)
3
PMA Approval
P
01
0054
Elecsys ANti-HBs
3
PMA Approval
P
10
0031
Elecsys Anti-HBc II
3
PMA Approval
P
03
0024
VITROS Immunodiagnostic Products Anti-HBc Reagent Pack and Calibrator
3
PMA Approval
P
04
0004
Atellica IM anti-HBc Total (HBcT)
3
PMA Approval
P
11
0041
Atellica IM HBsAgII (HBsII)/Atellica IM HBsAg Confirmatory
3
PMA Approval
P
10
0039
Atellica IM Anti-Hepatitis B Surface Antigen 2 (aHBs2)
3
PMA Approval
P
09
0024
Atellica IM Hepatitis B e Antigen (HBeAg)
3
PMA Approval
P
03
0040
Atellica IM Hepatitis B core IgM (aHBcM)
3
PMA Approval
P
03
0040
Atellica IM Hepatitis B core IgM (aHBcM) assay; Atellica IM Hepatitis B core lgM Quality Control (aHBcM QC)
3
PMA Approval
P
08
0023
ARCHITECT CORE, LN 6L22
3
PMA Approval
P
11
0029
ARCHITECT HBsAG Qualitative Reagent Kit (100/500 Test), ARCHITECT HBsAG Qualitative Confirmatory Reagent Kit
3
PMA Approval
P
01
0054
Elecsys Ani-HBs, PreciControl Anti-HBs and Anti-HBs CalCheck
3
PMA Approval
P
09
0024
Atellica IM Hepatitis B e Antigen (HBeAg)
3
PMA Approval
P
04
0004
Atellica IM Anti-Hepatitis B core Total (HBcT), Atellica IM Anti-Hepatitis B core Total Quality Control (HBcT QC)
3
PMA Approval
P
10
0001
VITROS Immunodiagnostic Products Anti-HBe Reagent Pack and Calibrator
3
PMA Approval
P
03
0026
VITROS Immunodiagnostic Products Anti-HBc IgM Reagent Pack and Calibrator
3
PMA Approval
P
00
0014
VITROS Immunodiagnostic Products Anti-HBs Quantitative Reagent Pack and Calibrator
3
PMA Approval
P
03
0024
VITROS Immunodiagnostic Products Anti-HBc Reagent Pack and Calibrator
3
PMA Approval
P
09
0028
VITROS Immunodiagnostic Products HBeAg Reagent Pack and Calibrator
3
PMA Approval
P
00
0044
VITROS Immunodiagnostic Products HBsAg Reagent Pack, Calibrator and Confirmatory Kit
3
PMA Approval
P
09
0028
VITROS Immunodiagnostic Products HBeAg Reagent Pack and Calibrator
3
PMA Approval
P
00
0014
VITROS Immunodiagnostic Products Anti-HBs Quantitative Reagent Pack and Calibrator
3
PMA Approval
P
10
0001
VITROS Immunodiagnostic Products Anti-HBe Reagent Pack and Calibrator
3
PMA Approval
P
00
0044
VITROS Immunodiagnostic Products HBsAg Reagent Pack, Calibrator and Confirmatory Kit
3
PMA Approval
P
03
0026
VITROS Immunodiagnostic Products Anti-HBc IgM Reagent Pack and Calibrator
3
PMA Approval
P
03
0024
VITROS Immunodiagnostic Products Anti-HBc Reagent Pack and Calibrator
3
PMA Approval
P
99
0043
ETI-EBK PLUS Assay
3
PMA Approval
P
99
0038
ETI-MAK-2 PLUS, HBsAg Confirmatory Test Assays
3
PMA Approval
P
99
0042
ETI-AB-AUK PLUS Assay
3
PMA Approval
P
99
0012
Elecsys HBsAg Immunoassay
3
PMA Approval
P
13
0015
Elecsys HBcAg
3
PMA Approval
P
11
0022
Elecsys Anti-HBc IgM
3
PMA Approval
P
10
0031
Elecsys Anti-HBc II
3
PMA Approval
P
16
0019
Elecsys HBsAg II
3
PMA Approval
P
01
0054
Elecsys Anti-HBs
3
PMA Approval
P
11
0041
Advia Centaur HBsll
3
PMA Approval
P
10
0039
Atellica IM Anti-Hepatitis B surface Antigen 2 (aHBs2), Atellica IM Anti-Hepatitis B surface Antigen 2 Quality Control (
3
PMA Approval
P
01
0054
Elecsys Anti-HBs, PreciControl Anti-HBs and Anti-HBs CalCheck
3
PMA Approval
P
03
0040
Atellica IM Hepatitis B core Antigen (aHBcM)
3
PMA Approval
P
99
0038
ETI-MAK-2 PLUS and HBsAg Confirmatory Test Assays
3
PMA Approval
P
99
0042
ETI-AB-AUK PLUS Assay
3
PMA Approval
P
99
0043
ETI-EBK PLUS Assay
3
PMA Approval
P
10
0032
Elecsys Anti-HBc II
3
PMA Approval
P
11
0031
Elecsys Anti-HBc IgM
3
PMA Approval
P
99
0012
Elecsys HBsAg Immunoassay
3
PMA Approval
P
01
0054
Elecsys Anti-HBs Immunoassay
3
PMA Approval
P
10
0031
Elecsys Anti-HBc II
3
PMA Approval
P
11
0041
ADVIA Centaur HBsAgII (HBsII), ADVIA Centaur HBsAg Confirmatory, ADVIA Centaur HBsAg Quality Control
3
PMA Approval
P
99
0043
ETI-EBK PLUS Assay
3
PMA Approval
P
99
0042
ETI-AB-AUK PLUS Assay
3
PMA Approval
P
99
0038
ETI-MAK-2 PLUS and HBsAg Confirmatory Test Assays
3
PMA Approval
P
13
0015
Elecsys HBeAg and PreciControl HBeAg
3
PMA Approval
P
03
0026
VITROS Immunodiagnostic Products Anti-HBc IgM Reagent Pack and Calibrator
3
PMA Approval
P
09
0028
HBeAg Reagent Pack and Calibrator
3
PMA Approval
P
10
0001
Vitros Immunodiagnostic Products Anti-HBe Reagent Pack and Calibrator
3
PMA Approval
P
10
0031
Elecsys Anti-HBc II, PreciControl Anti-HBc
3
PMA Approval
P
16
0019
Elecsys HBsAg II/Elecsys HBsAg Confirmatory Test/ PreciControl HBsAg II
3
PMA Approval
P
16
0019
Elecsys HBsAg II/Elecsys HBsAg Confirmatory Test/ PreciControl HBsAg II
3
PMA Approval
P
11
0022
Elecsys Anti-HBc IgM and PreciControl Anti-HBc IgM
3
PMA Approval
P
10
0031
Elecsys Anti-HBc II
3
PMA Approval
P
11
0031
Elecsys Anti-HBc IgM
3
PMA Approval
P
99
0012
Elecsys HBsAg Immunoassay
3
PMA Approval
P
11
0025
Elecsys Anti-HBc IgM
3
PMA Approval
P
01
0054
Elecsys Anti-HBs
3
PMA Approval
P
16
0019
Elecsys HBsAg II
3
PMA Approval
P
13
0015
Elecsys HBeAg
3
PMA Approval
P
10
0032
Elecsys Anti-HBc II
3
PMA Approval
P
11
0022
Elecsys Anti-HBc IgM
3
PMA Approval
P
00
0044
Vitros Immunodiagnostic Products HBs Ag Reagent Pack and Calibrator
3
PMA Approval
P
16
0019
Elecsys HBsAg II/Elecsys HBsAg Confirmatory Test/ PreciControl HBsAg II
3
PMA Approval
P
09
0028
VITROS Immunodiagnostic Products HBeAg Reagent Pack / VITROS Immunodiagnostic Products HBeAg Calibrator
3
PMA Approval
P
99
0038
ETI MAK-2 PLUS and HBsAg Confirmatory Test assays
3
PMA Approval
P
99
0043
ETI-EBK PLUS assay
3
PMA Approval
P
99
0042
ETI-AB-AUK PLUS assay
3
PMA Approval
P
11
0029
ARCHITECT HBSAG QUALITATIVE, QUALITATIVE CONFIRMATORY, CONFIRMATORY MANUAL DILUENT, CALIBRATORS, AND CONTROLS
3
PMA Approval
P
10
0001
VITROS Immunodiagnostic Products Anti-HBe Reagent Pack and Calibrator
3
PMA Approval
P
09
0028
VITROS IMMUNODIAGNOSTIC PRODUCTS HBEAG REAGENT PACK/PRODUCTS HBEAG CALIBRATOR/PRODUCTS HBE CONTROLS
3
PMA Approval
P
10
0001
VITROS ANTI-HBE REAGENT PACK/ANTI-HBE CALIBRATOR/ANTI HBE CONTROLS
3
PMA Approval
P
03
0024
VITROS Immunodiagnostic Products Anti-HBc Reagent Pack and Calibrator
3
PMA Approval
P
13
0015
Elecsys HBeAg
3
PMA Approval
P
10
0032
Elecsys Anti-HBc
3
PMA Approval
P
11
0031
Elecsys Anit-HBc IgM
3
PMA Approval
P
11
0025
Elecsys Anit-HBc IgM
3
PMA Approval
P
10
0031
Elecsys Anti-HBc
3
PMA Approval
P
01
0054
Elecsys Anit-HBs
3
PMA Approval
P
16
0019
Elecsys HBsAg II
3
PMA Approval
P
11
0022
Elecsys Anit-HBc IgM
3
PMA Approval
P
99
0012
Elecsys HBsAg
3
PMA Approval
P
13
0015
Elecsys HBeAg and PreciControl HBeAg
3
PMA Approval
P
10
0031
Elecsys Anti-HBc Immunoassay test system
3
PMA Approval
P
10
0032
Elecsys Anti-HBC Immunoassay test system
3
PMA Approval
P
00
0044
VITROS Immunodiagnostic Products HBsAg Reagent Pack; VITROS Immunodiagnostic Products HBsAg Calibrator
3
PMA Approval
P
11
0025
Elecsys Anti-HBc IgM Immunoassay
3
PMA Approval
P
11
0022
Elecsys Anti-HBc IgM Immunoassay
3
PMA Approval
P
11
0031
Elecsys Anti-HBc IgM Immunoassay
3
PMA Approval
P
10
0031
Elecsys Anti-HBc Immunoassay
3
PMA Approval
P
16
0019
Elecsys HBsAg II (100/200 tests) Immunoassay
3
PMA Approval
P
01
0054
Elecsys Anti-HBs Immunoassay
3
PMA Approval
P
13
0015
Elecsys HBeAg Immunoassay
3
PMA Approval
P
10
0032
Elecsys Anti-HBc Immunoassay
3
PMA Approval
P
99
0038
DiaSorin ETI-MAK-2 PLUS
3
PMA Approval
P
99
0042
DiaSorin ETI-AB-AUK PLUS assay
3
PMA Approval
P
99
0043
DiaSorin ETI-EBK PLUS assay
3
PMA Approval
P
99
0038
ETI MAK-2 PLUS and HBsAg Confirmatory Test assays
3
PMA Approval
P
99
0043
ETI-EBK PLUS assay
3
PMA Approval
P
99
0042
ETI-AB-AUK PLUS assay
3
PMA Approval
P
09
0024
ADVIA Centaur HBeAg
3
PMA Approval
P
11
0031
Elecsys Anti-HBc IgM, PreciControl Anti-HBc IgM
3
PMA Approval
P
11
0025
Elecsys Anti-HBc IgM, PreciControl Anti-HBc IgM
3
PMA Approval
P
11
0022
Elecsys Anti-HBc IgM, PreciControl Anti-HBc IgM
3
PMA Approval
P
11
0025
MODULAR ANALYSTICS E170
3
PMA Approval
P
11
0031
COBAS E 411
3
PMA Approval
P
11
0022
COBAS E 601
3
PMA Approval
P
13
0015
ELECSYS HBEAG AND PRECICONTROL HBEAG
3
PMA Approval
P
03
0040
ADVIA CENTAUR HBC IGM READYPACK REAGENTS, ADVIA CENTAUR HBC IGM QUALITY CONTROL MATERIALS
3
PMA Approval
P
16
0019
Elecsys HBsAg II/Elecsys HBsAg Confirmatory Test/ PreciControl HBsAg II
3
PMA Approval
P
11
0025
ELECSYS ANTI-HBC IGM IMMUNOASSAY & ELECSYS PREICONTROL ANTI-HBC IGM
3
PMA Approval
P
11
0022
ELECSYS ANTI-HBC IGM IMMUNOASSAY AND ELECSYS PRECICONTROL ANTI-HBC IGM
3
PMA Approval
P
11
0031
ELECSYS ANTI-HBC IGM IMMUNOASSAY AND ELECSYS PRECICONTROL ANTI-HBC IGM
3
PMA Approval
P
05
0051
ABBOTT ARCHITECT AUSAB
3
PMA Approval
P
01
0054
ELECSYS ANTI-HBS
3
PMA Approval
P
13
0015
ELECSYS HBEAG
3
PMA Approval
P
99
0012
ELECSYS HBSAG
3
PMA Approval
P
11
0029
ARCHITECT HBSAG QUALITATIVE, QUALITATIVE CONFIRMATORY,
3
PMA Approval
P
11
0041
ADVIA CENTAUR HBSAGII (HBSII);ADVIA CENTAUR XP HBSAG CONFIRMATORY
3
PMA Approval
P
13
0015
ELECSYS® HBEAG IMMUNOASSAY AND ELECSYS® PRECICONTROL HBEAG
3
PMA Approval
P
09
0024
ADVIA CENTAUR HEPATITIS B E ANTIGEN ASSAY
3
PMA Approval
P
10
0001
VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBE REAGENT PACK/ANTI-HBE CALIBRATOR
3
PMA Approval
P
10
0039
ADVIA CENTAUR ANTI HBS2 ASSAY
3
PMA Approval
P
04
0004
ADVIA CENTAUR HBC TOTAL ASSAY
3
PMA Approval
P
11
0025
ELECSYS ANTI-HBC IGM IMMUNOASSAY
3
PMA Approval
P
11
0031
ELECSYS ANTI-HBC IGM IMMUNOASSAY
3
PMA Approval
P
10
0031
Elecsys Anti-HBc II, PreciControl Anti-HBc
3
PMA Approval
P
01
0054
ELECSYS ANTI-HBS IMMUNOASSAY
3
PMA Approval
P
99
0012
ELECSYS HBSAG IMMUNOASSAY
3
PMA Approval
P
11
0022
ELECSYS ANTI-HBC IGM IMMUNOASSAY
3
PMA Approval
P
13
0015
ELECSYS HBEAG IMMUNOASSAY
3
PMA Approval
P
10
0032
ELECSYS ANTI-HBC IMMUNOASSAY
3
PMA Approval
P
05
0051
ABBOTT ARCHITECT AUSAB
3
PMA Approval
P
99
0042
ETI-AB-AUK PLUS ASSAY
3
PMA Approval
P
99
0043
DIASORIN ETI-EBK PLUS ASSAY
3
PMA Approval
P
99
0038
ETI-MAK-2 PLUS ASSAY AND HBsAg CONFIRMATORY TEST ASSAYS
3
PMA Approval
P
11
0029
ARCHITECT HBSAG QUALITATIVE, QUALITATIVE CONFIRMATORY, CONFIRMATORY MANUAL DILUENT, CALIBRATORS, AND CONTROLS
3
PMA Approval
P
00
0044
VITROS IMMUNODIAGNOSTIC PRODUCTS/HBSAG REAGENT PACK,VITROS IMMUNODIAGNOSTIC PRODUCTS CONFIRMATORY KIT, AND VITROS IMMUNR
3
PMA Approval
P
99
0012
ELECSYS HBSAG IMMUNOASSAY, ELECSYS HBSAG CONFIRMATORY, AND PRECICONTROL HBSAG
3
PMA Approval
P
10
0032
ELECSYS ANTI-HBC IMMUNOASSAY, ELECSYS PRECICONTROL ANTI-HBC FOR USE ON THE ELECSYS 2010 IMMUNOASSAY ANALYZER
3
PMA Approval
P
11
0022
ELECSYS ANTI-HBC IGM IMMUNOASSAY AND ELECSYS PRECICONTROL ANTI-HBC IGM
3
PMA Approval
P
13
0015
ELECSYS® HBEAG IMMUNOASSAY AND ELECSYS® PRECICONTROL HBEAG
3
PMA Approval
P
01
0054
ELECSYS ANTI-HBS
3
PMA Approval
P
11
0031
ELECSYS ANTI-HBC IGM IMMUNOASSAY AND ELECSYS PRECICONTROL ANTI-HBC IGM
3
PMA Approval
P
10
0031
ELECSYS ANTI-HBC IMMUNOASSAY & ELECSYS PRECICONTROL ANTI-HBC
3
PMA Approval
P
11
0025
ELECSYS ANTI-HBC IGM IMMUNOASSAY & ELECSYS PREICONTROL ANTI-HBC IGM FOR USE ON THE MODULAR ANAYTICS E170 IMMUNOASSAY ANA
3
PMA Approval
P
03
0040
ADVIA CENTAUR AHBCM ASSAY
3
PMA Approval
P
01
0054
ELECSYS ANTI-HBS TEST SYSTEM
3
PMA Approval
P
11
0031
ELECSYS ANTI-HBC IGM TEST SYSTEM
3
PMA Approval
P
11
0025
ELECSYS ANTI-HBC IGM TEST SYSTEM
3
PMA Approval
P
11
0022
ELECSYS ANTI-HBC IGM TEST SYSTEM
3
PMA Approval
P
10
0032
ELECSYS ANTI-HBC TEST SYSTEM
3
PMA Approval
P
10
0031
ELECSYS ANTI-HBC TEST SYSTEM
3
PMA Approval
P
99
0012
ELECSYS HBSAG TEST SYSTEM
3
PMA Approval
P
00
0014
VITROS IMMUNADIAGNOSTIC PRODUCTS ANTI-HBS QUANTITATIVE REAGENT PACK, VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBS CALIBRATO
3
PMA Approval
P
13
0015
ELECSYS HBEAG
3
PMA Approval
P
11
0031
ELECSYS ANTI-HBC-IGM
3
PMA Approval
P
11
0025
ELECSYS ANTI-HBC-IGM
3
PMA Approval
P
11
0022
ELECSYS ANTI-HBC-IGM
3
PMA Approval
P
10
0032
ELECSYS ANTI-HBC
3
PMA Approval
P
10
0031
ELECSYS ANTI-HBC
3
PMA Approval
P
01
0054
ELECSYS ANTI-HBS
3
PMA Approval
P
99
0012
ELECSYS HBSAG
3
PMA Approval
P
00
0044
VITROS IMMUNODIAGNOSTIC PRODUCTS HBSAG REGENT PACK, VITROS IMMUNODIAGNOSTIC PRODUCTS HBSAG CALIBRATOR
3
PMA Approval
P
03
0026
VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC IGM REAGENT PACK, VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC IGM CALIBRATOR
3
PMA Approval
P
10
0001
VITROS ANTI-HBE ASSAY
3
PMA Approval
P
03
0026
VITROS ANTI-HBC IGM ASSAY
3
PMA Approval
P
00
0014
VITROS ANTI-HBS ASSAY
3
PMA Approval
P
00
0044
VITROS HBSAG ASSAY
3
PMA Approval
P
03
0024
VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC REAGENT PACK AND CALIBRATOR
3
PMA Approval
P
09
0028
VITROS HBEAG ASSAY
3
PMA Approval
P
11
0029
ARCHITECT HBSAG QUALITATIVE (LN 4P53), ARCHITECT HBSAG QUALITATIVE CONFIRMATORY (LN 4P54)
3
PMA Approval
P
05
0051
ARCHITECT AUSAB (LN 1L82)
3
PMA Approval
P
08
0023
ARCHITECT CORE (LN 6L22)
3
PMA Approval
P
06
0035
ARCHITECT CORE-M (LN 6L23)
3
PMA Approval
P
13
0015
ELECSYS HBEAG IMMUNOASSAY/ELECSYS PRECICONTROL HBEAG
3
PMA Approval
P
01
0052
IMMULITE ANTI-HEPATITIS B SURFACE ANTIGEN (ANTI-HBS) SYSTEMS
3
PMA Approval
P
00
0014
VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBS REAGENT PACK AND CALIBRATOR
3
PMA Approval
P
09
0028
VITROS IMMUNODIAGNOSTIC PRODUCTS HBEAG REAGENT PACK AND CALIBRATOR
3
PMA Approval
P
10
0001
VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBE REAGENT PACK AND CALIBRATOR
3
PMA Approval
P
03
0024
VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC REAGENT PACK AND CALIBRATOR
3
PMA Approval
P
00
0044
VITROS IMMUNODIAGNOSTIC PRODUCTS HBSAG REAGENT PACK AND CALIBRATOR
3
PMA Approval
P
11
0029
ARCHITECT HBSAG QUALITATIVE(LN 4P53), ARCHITECT HBSAG QUALITATIVE CONFIRMATORY (LN 4P54) ASSAYS
3
PMA Approval
P
03
0049
ADVIA CENTAUR HBSAG ASSAY
3
PMA Approval
P
11
0041
ADVIA CENTAUR HBSAGII ASSAY
3
PMA Approval
P
10
0039
ADVIA CENTAUR ANTI-HBS2 (AL-BS2) ASSAY
3
PMA Approval
P
04
0004
ADVIA CENTAUR HBC TOTAL ASSAY
3
PMA Approval
P
09
0024
ADVIA CENTAUR HBEAG ASSAY
3
PMA Approval
P
03
0040
ADVIA CENTAUR HBC IGM ASSAY
3
PMA Approval
P
04
0004
ADVIA CENTAUR HBC TOTAL READYPACK REAGENTS, ADVIA CENTAUR HBC TOTAL QUALITY CONTROL
3
PMA Approval
P
03
0026
VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC IGM REAGENT PACK AND CALIBRATOR
3
PMA Approval
P
11
0041
ADVIA CENTAUR HBSAGII ASSAY
3
PMA Approval
P
05
0051
ARCHITECT AUSAB PMA ASSAY
3
PMA Approval
P
11
0029
ARCHITECT HBSAG QUALITATIVE/CONFIRMATORY PMA ASSAYS
3
PMA Approval
P
01
0054
ELECSYS ANTI-HBS CALCHECK
3
PMA Approval
P
99
0012
ELECSYS HBSAG CONFIRMATORY TEST
3
PMA Approval
P
11
0029
ARCHITECT HBSAG QUALITATIVE AND ARCHITECT HBSAG QUALITATIVE CONFIRMATORY
3
PMA Approval
P
00
0014
VITROS IMMUNODIAGNOSTIC ANTI-HBS QUANTITATIVE REAGENT PACK, VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBS CALIBRATORS
3
PMA Approval
P
11
0029
ARCHITECT HBSAG QUALITATIVE
3
PMA Approval
P
05
0051
ARCHITECT AUSAB
3
PMA Approval
P
08
0023
ARCHITECT CORE
3
PMA Approval
P
06
0035
ARCHITECT CORE-M
3
PMA Approval
P
11
0022
ELECSYS ANTI-HBC IGM ON COBAS E 601
3
PMA Approval
P
10
0031
ELECSYS ANTI-HBC ON COBAS E 601
3
PMA Approval
P
11
0025
ELECSYS ANTI-HBC IGM ON MODULAR ANALYTICS E170
3
PMA Approval
P
13
0015
ELECSYS HBEAG ON MODULAR ANALYTICS E170
3
PMA Approval
P
01
0050
IMMULITE HBSAG, IMMULITE 2000 HBSAG
3
PMA Approval
P
05
0051
ARCHITECT AUSAB (LN 1L82)
3
PMA Approval
P
03
0049
ADVIA CENTAUR HBSAG (HBS) ASSAY
3
PMA Approval
P
08
0023
ARCHITECT CORE (LN 6L22)
3
PMA Approval
P
06
0035
ARCHITECT CORE-M (LN 6L23)
3
PMA Approval
P
99
0045
ETI-AB-COREK PLUS ASSAY
3
PMA Approval
P
99
0042
ETI-AB-AUK-PLUS
3
PMA Approval
P
99
0043
ETI-EBK PLUS ASSAY
3
PMA Approval
P
99
0044
ETI-CORE-IGMK PLUS ASSAY
3
PMA Approval
P
99
0038
ETI-MAK-2 PLUS ASSAY
3
PMA Approval
P
99
0041
ETI-AB-EBK PLUS ASSAY
3
PMA Approval
P
10
0031
ELECSYS ANTI-HBC
3
PMA Approval
P
01
0054
ELECSYS ANTI-HBS
3
PMA Approval
P
99
0012
ELECSYS HBS AG
3
PMA Approval
P
11
0022
ELESYS ANTI-HBC IGM
3
PMA Approval
P
13
0015
ELECSYS HBEAG IMMUNOASSAY AND ELECSYS PRECICONTROL HBEAG
3
PMA Approval
P
11
0041
ADVIA CENTAUR HBSAGII
3
PMA Approval
P
05
0051
ARCHITECT AUSAB
3
PMA Approval
P
11
0029
ARCHITECT HBSAG QUALITATIVE/CONFIRMATORY
3
PMA Approval
P
01
0054
ELECSYS ANTI-HBS IMMUNOASSAY
3
PMA Approval
P
10
0032
ELECSYS ANTI-HBC IMMUNOASSAY
3
PMA Approval
P
99
0012
ELECSYS HBSAG IMMUNOASSAY
3
PMA Approval
P
06
0034
MONOLISA ANTI-HBC IGM EIA
3
PMA Approval
P
13
0015
ELECSYS® HBEAG IMMUNOASSAY AND ELECSYS® PRECICONTROL HBEAG
3
PMA Approval
P
00
0014
ANTI-HBS QUANTITATIVE REAGENT PACK AND CALIBRATORS
3
PMA Approval
P
99
0042
ETI-AB-AUK PLUS ASSAY
3
PMA Approval
P
99
0038
ETI-MAK-2 PLUS ASSAY
3
PMA Approval
P
99
0041
ETI-AB-EBK PLUS ASSAY
3
PMA Approval
P
99
0043
ETI-EBK PLUS
3
PMA Approval
P
99
0044
ETI-CORE-IGMK PLUS
3
PMA Approval
P
99
0045
ETI-AB-COREK PLUS ASSAY
3
PMA Approval
P
05
0051
ARCHITECT AUSAB ASSAY
3
PMA Approval
P
10
0031
ELECSYS ANTI-HBC TEST SYSTEM
3
PMA Approval
P
11
0022
ELECSYS ANTI-HBC IGM TEST SYSTEM
3
PMA Approval
P
10
0032
ELECSYS ANTI-HBC TEST SYSTEM
3
PMA Approval
P
06
0031
BIO-RAD MONOLISA ANTI-HBC EIA
3
PMA Approval
P
05
0048
BIO-RAD MONOLISA ANTI-HBS EIA
3
PMA Approval
P
06
0034
BIO-RAD MONOLISA ANTI-HBC IGM EIA
3
PMA Approval
P
11
0029
ARCHITECT HBSAG QUALITATIVE/CONFIRMATORY
3
PMA Approval
P
08
0023
ARCHITECT CORE
3
PMA Approval
P
11
0029
ARCHITECT HBSAG QUAL/CONF
3
PMA Approval
P
05
0051
ARCHITECT AUSAB
3
PMA Approval
P
06
0035
ARCHITECT CORE-M
3
PMA Approval
P
06
0035
ARCHITECT CORE-M
3
PMA Approval
P
11
0029
ARCHITECT HBSAG QUALITATIVE/CONFIRMATORY
3
PMA Approval
P
05
0051
ARCHITECT AUSAB
3
PMA Approval
P
08
0023
ARCHITECT CORE
3
PMA Approval
P
11
0029
ARCHITECT HBSAG QUALITATIVE CONFIRMATORY , LN 4P54
3
PMA Approval
P
05
0051
ARCHITECT AUSAB LN 1L82
3
PMA Approval
P
10
0001
VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBE REAGENT PACK AND CALIBRATOR
3
PMA Approval
P
09
0028
VITROS IMMUNODIAGNOSTIC PRODUCTS HBEAG REAGENT PACK AND CALIBRATOR
3
PMA Approval
P
03
0026
VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC IGM REAGENT PACK AND CALIBRATOR
3
PMA Approval
P
10
0039
ADVIA CENTAUR ANTI-HBS2 ASSAY
3
PMA Approval
P
08
0023
ARCHITECT CORE
3
PMA Approval
P
10
0039
ADVIA CENTAUR ANTI-HBS2 MASTER CURVE MATERIALS
3
PMA Approval
P
03
0024
VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC REAGENT PACK AND CALIBRATOR
3
PMA Approval
P
10
0031
ELECSYS ANTI-HBC IMMUNOASSAY AND ELECSYS PRECICONTROL ANTI-HBC
3
PMA Approval
P
11
0029
ABBOTT ARCHITECT HBSAG QUALITATIVE CONFIRMATORY REAGENT
3
PMA Approval
P
11
0031
ELECSYS ANTI-HBC IGM ASSAY (COBAS E 411 ANALYZER)
3
PMA Approval
P
11
0022
ELECSYS ANTI-HBC IGM ASSAY (COBAS E 601 ANALYZER)
3
PMA Approval
P
11
0025
ELECSYS ANTI-HBC IGM ASSAY (MODULAR ANALYTICS E170 ANALYZER)
3
PMA Approval
P
06
0007
ARCHITECT HBSAG/HBSAG CONFIRMATORY
3
PMA Approval
P
05
0051
ARCHITECT AUSAB
3
PMA Approval
P
99
0045
ETI-AB-COREK PLUS
3
PMA Approval
P
99
0038
ETI-MAK-2 PLUS ASSAY
3
PMA Approval
P
99
0041
ETI-AB-EBK PLUS ASSAY
3
PMA Approval
P
99
0042
ETI-AB-AUK PLUS ASSAY
3
PMA Approval
P
99
0043
ETI-EBK PLUS ASSAY
3
PMA Approval
P
99
0044
ETI-CORE-IGMK PLUS
3
PMA Approval
P
99
0012
ELECSCYS HBSAG IMMUNOASSAY, ELECSYS PRECICONTROL HBSAG, ELECSYS HBSAG CONFIRMATORY TEST
3
PMA Approval
P
06
0035
ARCHITECT CORE-M
3
PMA Approval
P
08
0023
ARCHITECT CORE
3
PMA Approval
P
06
0007
ARCHITECT HBSAG/CONFIRMATORY
3
PMA Approval
P
08
0023
ARCHITECT CORE
3
PMA Approval
P
05
0051
ARCHITECT AUSAB
3
PMA Approval
P
06
0035
ARCHITECT CORE-M
3
PMA Approval
P
11
0029
ARCHITECT HBSAG QUALITATIVE/CONFIRMATORY
3
PMA Approval
P
11
0029
ARCHITECT I1000 SYSTEM
3
PMA Approval
P
10
0001
VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBE
3
PMA Approval
P
03
0026
VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC IGM
3
PMA Approval
P
09
0028
VITROS IMMUNODIAGNOSTIC PRODUCTS ABEAG
3
PMA Approval
P
01
0054
PRECICONTROL ANTI-HBS
3
PMA Approval
P
99
0012
PRECICONTROL HBSAG
3
PMA Approval
P
10
0031
PRECICONTROL ANTI-HBC (MODULAR ANALYTICS E170)
3
PMA Approval
P
11
0031
PRECICONTROL ANTI-HBC IGM (COBAS E 411)
3
PMA Approval
P
11
0025
PRECICONTROL ANTI-HBC IGM (MODULAR ANALYTICS E170)
3
PMA Approval
P
10
0032
PRECICONTROL ANTI-HBC (ELECSYS) 2010
3
PMA Approval
P
11
0022
PRECICONTROL ANTI-HBC IGM (COBAS E 601)
3
PMA Approval
P
10
0032
ELECSYS ANTI-HBC ON ELECSYS 2010
3
PMA Approval
P
99
0012
ELECSYS HBSAG
3
PMA Approval
P
01
0054
ELECSYS ANTI-HBS
3
PMA Approval
P
11
0031
ELECSYS ANTI-HBC IGM ON COBAS E 411
3
PMA Approval
P
11
0025
ELECSYS ANTI-HBC IGM ON MODULAR ANALYTICS E170
3
PMA Approval
P
11
0022
ELECSYS ANTI-HBC IGM ON COBAS E 601
3
PMA Approval
P
10
0031
ELECSYS ANTI-HBC ON MODULAR ANALYTICS E170
3
PMA Approval
P
06
0007
ARCHITECT HBSAG/CONFIRMATORY
3
PMA Approval
P
08
0023
ARCHITECT CORE
3
PMA Approval
P
05
0051
ARCHITECT AUSAB
3
PMA Approval
P
11
0029
ARCHITECT HBSAG QUALITTATIVE/CONFIRMATORY
3
PMA Approval
P
06
0035
ARCHITECT CORE-M
3
PMA Approval
P
08
0023
ARCHITECT CORE
3
PMA Approval
P
06
0035
ARCHITECT CORE-M
3
PMA Approval
P
06
0007
ARCHITECT HBSAG/CONFIRMATORY
3
PMA Approval
P
11
0029
ARCHITECT HBSAG QUALITATIVE/CONFIRMATORY
3
PMA Approval
P
05
0051
ARCHITECT AUSAB
3
PMA Approval
P
08
0023
ARCHITECT CORE
3
PMA Approval
P
06
0012
AXSYM CORE 2.0
3
PMA Approval
P
06
0009
AXSYM CORE-M 2.0
3
PMA Approval
P
05
0051
ARCHITECT AUSAB
3
PMA Approval
P
06
0007
ARCHITECT HBSAG/HBSAG CONFIRMATORY
3
PMA Approval
P
11
0029
ARCHITECT HBSAG QUALITATIVE/HBSAG QUALITATIVE CONFIRMATORY
3
PMA Approval
P
06
0035
ARCHITECT CORE-M
3
PMA Approval
P
05
0049
AXSYM HBSAG/HBSAG CONFIRMATORY
3
PMA Approval
P
06
0003
AXSYM AUSAB
3
PMA Approval
P
99
0043
ETI-EBK PLUS ASSAY
3
PMA Approval
P
99
0045
ETI-AB-COREK PLUS ASSAY
3
PMA Approval
P
99
0044
ETI-CORE-IGMK PLUS ASSAY
3
PMA Approval
P
99
0042
ETI-AB-AUK PLUS ASSAY
3
PMA Approval
P
99
0041
ETI-AB-EBK PLUS ASSAY
3
PMA Approval
P
99
0038
ETI-MAK-2 PLUS ASSAY
3
PMA Approval
P
05
0051
ARCHITECT AUSAB
3
PMA Approval
P
11
0029
ARCHITECT HBSAG QUALITATIVE/CONFIMATORY
3
PMA Approval
P
06
0007
ARCHITECT HBSAG/CONFIMATORY
3
PMA Approval
P
06
0035
ARCHITECT CORE-M
3
PMA Approval
P
08
0023
ARCHITECT CORE
3
PMA Approval
P
09
0028
VITROS IMMUNODIAGNOSTIC PRODUCTS HBEAG REAGENT PACK CALIBRATOR
3
PMA Approval
P
11
0029
ARCHITECT HBSAG QUALITATIVE/CONFIRMATORY
3
PMA Approval
P
10
0001
VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBE REAGENT PACK, VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBE CALIBRATOR
3
PMA Approval
P
06
0034
BIO-RAD MONOLISA ANTI-HBC IGM EIA
3
PMA Approval
P
05
0048
BIO-RAD MONOLISA ANTI-HBS EIA
3
PMA Approval
P
06
0031
BIO-RAD MONOLISA ANTI-HBC EIA
3
PMA Approval
P
09
0028
VITROS IMMUNODIAGNOSTIC PRODUCTS HBEAG REAGENT PACK AND CALIBRATOR
3
PMA Approval
P
00
0044
VITROS IMMUNODIAGNOSTIC PRODUCTS HBSAG REAGENT PACK AND CALIBRATOR
3
PMA Approval
P
03
0026
VITROS ANTI-HBC IGM
3
PMA Approval
P
00
0014
VITROS ANTI-HBS
3
PMA Approval
P
03
0024
VITROS ANTI-HBC
3
PMA Approval
P
10
0001
VITROS ANTI-HBE
3
PMA Approval
P
05
0048
BIO-RAD MONOLISA ANTI-HBS EIA AND MONOLISA ANTI-HBS CALIBRATOR KIT
3
PMA Approval
P
99
0012
ELECSYS HBSAG IMMUNOASSAY, ELECSYS PRECICONTROL HBSAG AND ELECSYS HBSAG CONFIRMATORY TEST SYSTEM
3
PMA Approval
P
99
0012
ELECSYS HBSAG IMMUNOASSAY, ELECSYS PRECICONTROL HBSAG AND ELECSYS HBSAG CONFIRMATORY TEST SYSTEM
3
PMA Approval
P
10
0001
VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBE REAGENT PACK AND CALIBRATOR
3
PMA Approval
P
09
0028
VITROS IMMUNODIAGNOSTIC PRODUCTS HBEAG REAGENT PACK AND CALIBRATOR
3
PMA Approval
P
06
0007
ABBOTT ARCHITECT HBSAG/ARCHITECT HBSAG CONFIRMATORY
3
PMA Approval
P
11
0029
ABBOTT ARCHITECT HBSAG QUALITATIVE/ ARCHITECT HBSAG QUALITATIVE CONFIRMATORY
3
PMA Approval
P
04
0004
ADVIA CENTAUR HBC TOTAL ASSAY
3
PMA Approval
P
03
0029
ADVIA CENTAUR ANTI-HBS ASSAY
3
PMA Approval
P
03
0040
ADVIA CENTAUR HBC IGM ASSAY
3
PMA Approval
P
03
0049
ADVIA CENTAUR HBSAG AND HBSAG CONFIRMATORY ASSAYS
3
PMA Approval
P
06
0007
ABBOTT ARCHITECT HBSAG/ ARCHITECT HBS/AG CONFIRMATORY
3
PMA Approval
P
11
0029
ABBOTT ARCHITECT HBSAG QUALITATIVE/ ARCHITECT HBSAG QUALITATIVE CONFIRMATORY
3
PMA Approval
P
08
0023
ARCHITECT CORE
3
PMA Approval
P
05
0051
ARCHITECT AUSAB
3
PMA Approval
P
06
0007
ARCHITECT HBSAG/CONFIRMATORY
3
PMA Approval
P
11
0029
ARCHITECT HBSAG QUALITTATIVE/CONFIRMATORY
3
PMA Approval
P
06
0035
ARCHITECT CORE-M
3
PMA Approval
P
11
0029
ABBOTT ARCHITECT HBSAG QUALITATIVE / ARCHITECT HBSAG QUALITATIVE CONFIRMATORY
3
PMA Approval
P
06
0007
ABBOTT ARCHITECT HBSAG/ ARCHITECT HBSAG CONFIRMATORY
3
PMA Approval
P
11
0022
ELECSYS ANTI-HBC-IGM ON COBAS E 601
3
PMA Approval
P
11
0025
ELECSYS ANTI-HBC-IGM ON MODULAR ANALYTICS E170
3
PMA Approval
P
11
0031
ELECSYS ANTI-HBC-IGM ON COBAS E 411
3
PMA Approval
P
03
0024
VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC REAGENT PACK AND CALIBRATOR
3
PMA Approval
P
01
0054
ELECSYS ANTI-HBS (ANTI-HBS) TEST SYSTEM
3
PMA Approval
P
10
0001
VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBE REAGENT PACK AND CALIBRATOR
3
PMA Approval
P
09
0028
VITROS IMMUNODIAGNOSTIC PRODUCTS HBEAG REAGENT PACK AND CALIBRATOR
3
PMA Approval
P
08
0023
ARCHITECT CORE
3
PMA Approval
P
08
0023
ARCHITECT CORE
3
PMA Approval
P
11
0029
ARCHITECT HBSAG QUALITATIVE, QUALITATIVE CONFIRMATORY, CONFIRMATORY MANUAL DILUENT, CALIBRATORS, AND CONTROLS
3
PMA Approval
P
11
0025
ELECSYS ANTI-HBC IGM ON MODULAR ANALYTICS E170
3
PMA Approval
P
11
0031
ELECSYS ANTI-HBC IGM ON COBAS E 411
3
PMA Approval
P
01
0054
ELECSYS ANTI-HBS
3
PMA Approval
P
10
0031
ELECSYS ANTI-HBC ON MODULAR ANALYTICS E170
3
PMA Approval
P
99
0012
ELECSYS HBSAG
3
PMA Approval
P
11
0022
ELECSYS ANTI-HBC IGM ON COBAS E 601
3
PMA Approval
P
10
0032
ELECSYS ANTI-HBC ON ELECSYS 2010
3
PMA Approval
P
01
0053
ANTI-HBCM IMMULITE SUBSTRATE REAGENT
3
PMA Approval
P
01
0050
HBSAG IMMULITE SUBSTRATE REAGENT
3
PMA Approval
P
01
0051
ANTI-HBC IMMULITE SUBSTRATE REAGENT
3
PMA Approval
P
01
0052
ANTI-HBS IMMULITE SUBSTRATE REAGENT
3
PMA Approval
P
99
0012
ELECSYS HBSAG (HBSAG) TEST SYSTEM
3
PMA Approval
P
00
0014
VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBS QUANTITATIVE REAGENT PACK AND CALIBRATOR
3
PMA Approval
P
99
0045
ETI-AB-COREK PLUS ASSAY
3
PMA Approval
P
99
0043
ETI-EBK-PLUS
3
PMA Approval
P
99
0044
ETI-CORE-IGMK PLUS ASSAY
3
PMA Approval
P
99
0042
ETI-AB-AUK PLUS ASSAY
3
PMA Approval
P
99
0041
ETI-AB-EBK PLUS ASSAY
3
PMA Approval
P
99
0038
ETI-MAK-2 PLUS ASSAY
3
PMA Approval
P
06
0035
ARCHITECT CORE-M
3
PMA Approval
P
08
0023
ARCHITECT CORE
3
PMA Approval
P
05
0049
AXSYM HBSAG
3
PMA Approval
P
11
0031
ELECSYS ANTI-HBC-IGM ON COBAS E 411
3
PMA Approval
P
11
0022
ELECSYS ANTI-HBC-IGM ON COBAS E 601
3
PMA Approval
P
11
0025
ELECSYS ANTI-HBC-IGM ON MODULAR ANALYTICS E170
3
PMA Approval
P
11
0031
ELECSYS ANTI-HBC-IGM ON COBAS E 411
3
PMA Approval
P
11
0022
ELECSYS ANTI-HBC-IGM ON COBAS E 601
3
PMA Approval
P
11
0025
ELECSYS ANTI-HBC-IGM ON MODULAR ANALYTICS E170
3
PMA Approval
P
11
0031
ELECSYS ANTI-HBC-IGM ON COBAS E 411
3
PMA Approval
P
11
0025
ELECSYS ANTI-HBC-IGM ON MODULAR ANALYTICS E170
3
PMA Approval
P
11
0022
ELECSYS ANTI-HBC-IGM ON COBAS E 601
3
PMA Approval
P
03
0024
VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC REAGENT PACK AND CALIBRATOR
3
PMA Approval
P
03
0026
VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC IGM REAGENT PACK CALIBRATOR
3
PMA Approval
P
00
0044
VITROS IMMUNODIAGNOSTIC PRODUCTS HBSAG REAGENT PACK AND CALIBRATOR
3
PMA Approval
P
04
0004
ADVIA CENTAUR HBC TOTAL ASSAY
3
PMA Approval
P
10
0039
ADVIA CENTAUR ANTI-HBS2 (AHBS2) ASSAY AND QAULITY CONTROL MATERIAL
3
PMA Approval
P
06
0007
ABBOTT ARCHITECT HBSAG & HBSAG CONFIRMATORY
3
PMA Approval
P
11
0031
ELECSYS ANTI-HBC IGM IMMUNOASSAY AND ELECSYS PRECICONTROL ANTI-HBC IGM
3
PMA Approval
P
06
0012
AXSYM CORE 2.0 (LN 8B88)
3
PMA Approval
P
06
0003
AXSYM AUSAB (LN 3C74)
3
PMA Approval
P
05
0049
AXSYM HBSAG/CONFIRMATORY (LN 9B01)
3
PMA Approval
P
06
0009
AXSYM CORE-M 2.0 (LN 3B89)
3
PMA Approval
P
05
0051
ARCHITECT AUSAB
3
PMA Approval
P
06
0007
ARCHITECT HBSAG/CONFIRMATORY
3
PMA Approval
P
08
0023
ARCHITECT CORE
3
PMA Approval
P
06
0035
ARCHITECT CORE-M
3
PMA Approval
P
11
0025
ELECSYS ANTI-HBC IGM IMMUNOASSAY & ELECSYS PREICONTROL ANTI-HBC IGM FOR USE ON THE MODULAR ANAYTICS E170 IMMUNOASSAY ANA
3
PMA Approval
P
06
0035
ARCHITECT CORE-M
3
PMA Approval
P
08
0023
ARCHITECT CORE
3
PMA Approval
P
10
0032
ELECSYS ANTI-HBC IMMUNOASSAY ON ELECSYS 2010
3
PMA Approval
P
99
0012
ELECSYS HBSAG IMMUNOASSAY
3
PMA Approval
P
01
0054
ELECSYS ANTI-HBS IMMUNOASSAY
3
PMA Approval
P
10
0031
ELECSYS ANTI-HBC IMMUNOASSAY ON MODULAR ANALYTICS E170
3
PMA Approval
P
10
0032
ELECSYS ANTI-HBC IMMUNOASSAY ON ELECSYS 2010
3
PMA Approval
P
10
0031
ELECSYS ANTI-HBC IMMUNOASSAY ON MODULAR ANALYSTICS E170
3
PMA Approval
P
99
0012
ELECSYS HBSAG IMMUNOASSAY
3
PMA Approval
P
99
0042
ETI-AB-AUK PLUS KIT
3
PMA Approval
P
99
0045
ETI-AB-COREK PLUS KIT
3
PMA Approval
P
99
0041
ETI-AB-EBK PLUS KIT
3
PMA Approval
P
99
0044
ETI-CORE-IGMK PLUS KIT
3
PMA Approval
P
99
0038
ETI-MAK-2 PLUS KIT
3
PMA Approval
P
05
0049
ABBOTT AXSYM HBSAG
3
PMA Approval
P
00
0014
VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBS ASSAY
3
PMA Approval
P
00
0044
VITROS IMMUNODIAGNOSTIC PRODUCTS HBSAG ASSAY AND HBSAG CONFIRMATORY KIT
3
PMA Approval
P
03
0026
VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC IGM ASSAY
3
PMA Approval
P
03
0024
VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC ASSAY
3
PMA Approval
P
11
0022
ELECSYS ANTI-HBC IGM IMMUNOASSAY AND ELECSYS PRECICONTROL ANTI-HBC IGM
3
PMA Approval
P
09
0028
VITROS IMMUNODIAGNOSTIC PRODUCTS HBEAG REAGENT PACK & CALIBRATOR
3
PMA Approval
P
09
0024
ADVIA CENTAUR HBEAG ASSAY AND QUALITY CONTROL MATERIAL
3
PMA Approval
P
06
0012
AXSYM CORE
3
PMA Approval
P
06
0035
ARCHITECT CORE-M
3
PMA Approval
P
06
0003
ABBOTT AXSYM AUSAB
3
PMA Approval
P
03
0024
VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC REAGENT PACK & CALIBRATOR
3
PMA Approval
P
03
0026
VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC IGM REAGENT PACK & CALIBRATOR
3
PMA Approval
P
10
0031
ELECSYS ANTI-HBC IMMUNOASSAY ON THE MODULAR ANALYSTICS E170 IMMUNOASSAY ANALYZER
3
PMA Approval
P
10
0032
ELECSYS ANTI-HBC IMMUNOASSAY ON THE ELECSYS 2010 IMMUNOASSAY ANALYZER
3
PMA Approval
P
01
0054
ELECSYS ANTI-HBS IMMUNOASSAY & ELECSYS PRECICONTROL ANTI-HBS
3
PMA Approval
P
99
0012
ELECSYS HBSAG IMMUNOASSAY & CONFIRMATORY & PRECICONTROL HBSAG
3
PMA Approval
P
00
0044
VITROS IMMUNODIAGNOSTIC PRODUCTS HBSAG REAGENT PACK AND CALIBRATOR
3
PMA Approval
P
99
0043
ETI-EBK PLUS KIT
3
PMA Approval
P
01
0052
IMMULITE/IMMULITE 1000 & IMMULITE 2000 ANTI-HBS
3
PMA Approval
P
01
0051
IMMULITE/IMMULITE 1000 & IMMULITE 2000 ANTI-HBC
3
PMA Approval
P
01
0050
IMMULITE/IMMULITE 1000 & IMMULITE 2000 HBSAG & 2000 HBSAG CONFIRMATORY
3
PMA Approval
P
01
0053
IMMULITE/IMMULITE 1000 & IMMULITE 2000 ANTI-HBC
3
PMA Approval
P
01
0050
HBSAG IMMULITE ASSAY
3
PMA Approval
P
01
0053
ANTI-HBCM IMMULITE ASSAY
3
PMA Approval
P
01
0051
ANTI-HBC IMMULITE ASSAY
3
PMA Approval
P
01
0052
ANTI-HBS IMMULITE ASSAY
3
PMA Approval
P
01
0054
ELECSYS ANTI-HBS IMMUNOASSAY
3
PMA Approval
P
10
0031
ELECSYS ANTI-HBC IMMUNOASSAY
3
PMA Approval
P
10
0032
ELECSYS ANTI-HBC IMMUNOASSAY
3
PMA Approval
P
05
0051
ARCHITECT AUSAB
3
PMA Approval
P
06
0007
ARCHITECT HBSAG/CONFIRMATORY
3
PMA Approval
P
08
0023
ARCHITECT CORE
3
PMA Approval
P
06
0035
ARCHITECT CORE-M
3
PMA Approval
P
10
0001
VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBE REAGENT PACK/ANTI-HBE CALIBRATOR/ANTI HBE CONTROLS
3
PMA Approval
P
05
0049
ABBOTT AXSYM HBSAG & HBSAG CONFIRMATORY
3
PMA Approval
P
10
0032
ELECSYS ANTI-HBC IMMUNOASSAY, ELECSYS PRECICONTROL ANTI-HBC FOR USE ON THE ELECSYS 2010 IMMUNOASSAY ANALYZER
3
PMA Approval
P
06
0035
ARCHITECT CORE-M
3
PMA Approval
P
06
0007
ARCHITECT HBSAG/CONFIRMATORY
3
PMA Approval
P
05
0051
ARCHITECT AUSAB
3
PMA Approval
P
08
0023
ARCHITECT CORE
3
PMA Approval
P
01
0050
IMMULITE 2000 HBS AG CONFIRMATORY KIT
3
PMA Approval
P
10
0031
ELECSYS ANTI-HBC IMMUNOASSAY & ELECSYS PRECICONTROL ANTI-HBC
3
PMA Approval
P
03
0026
VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC IGM REAGENT PACK & CALIBRATOR
3
PMA Approval
P
06
0003
ABBOTT AXSYM AUSAB
3
PMA Approval
P
06
0007
ARCHITECT HBSAG/CONFIMATORY
3
PMA Approval
P
06
0035
ARCHITECT CORE-M
3
PMA Approval
P
08
0023
ARCHITECT CORE
3
PMA Approval
P
05
0051
ARCHITECT AUSAB
3
PMA Approval
P
06
0035
ARCHITECT CORE-M
3
PMA Approval
P
08
0023
ARCHITECT CORE
3
PMA Approval
P
05
0049
AXSYM HBSAG/CONFIRMATORY
3
PMA Approval
P
06
0003
AXSYM AUSAB
3
PMA Approval
P
06
0012
AXSYM CORE
3
PMA Approval
P
06
0009
AXSYM CORE-M
3
PMA Approval
P
08
0023
ARCHITECT CORE
3
PMA Approval
P
06
0035
ARCHITECT CORE-M
3
PMA Approval
P
06
0007
ARCHITECT HBSAG/CONFIRMATORY
3
PMA Approval
P
05
0051
ARCHITECT AUSAB
3
PMA Approval
P
06
0003
ABBOTT AXSYM AUSAB
3
PMA Approval
P
01
0051
ANTI-HBC
3
PMA Approval
P
01
0053
ANTI-HBC IGM
3
PMA Approval
P
01
0052
ANTI-HBS
3
PMA Approval
P
01
0050
HBSAG
3
PMA Approval
P
00
0044
VITROS IMMUNODIAGNOSTICS PRODUCTS HBSAG REAGENT PACK & CALIBRATOR
3
PMA Approval
P
03
0024
VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC REAGENT PACK & CALIBRATOR
3
PMA Approval
P
09
0028
VITROS IMMUNODIAGNOSTIC PRODUCTS HBEAG REAGENT PACK/PRODUCTS HBEAG CALIBRATOR/PRODUCTS HBE CONTROLS
3
PMA Approval
P
01
0054
ELECSYS ANTI-HBS IMMUNOASSAY
3
PMA Approval
P
99
0012
ELECSYS HBSAG IMMUNOASSAY
3
PMA Approval
P
06
0031
BIO-RAD MONOLISA ANTI-HBC EIA
3
PMA Approval
P
05
0048
BIO-RAD MONOLISA ANTI-HBS EIA
3
PMA Approval
P
03
0026
VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC IGM REAGENT PACK & CALIBRATOR
3
PMA Approval
P
06
0007
ABBOTT ARCHITECT HBSAG & ARCHITECT HBSAG CONFIRMATORY ASSAYS
3
PMA Approval
P
06
0012
AXSYM CORE 2.0
3
PMA Approval
P
06
0009
AXSYM CORE-M 2.0
3
PMA Approval
P
06
0003
AXSYM AUSAB
3
PMA Approval
P
06
0012
AXSYM CORE 2.0
3
PMA Approval
P
05
0049
AXSYM HBSAG/CONFIRMATORY
3
PMA Approval
P
06
0009
AXSYM CORE-M 2.0
3
PMA Approval
P
05
0051
ARCHITECT AUSAB
3
PMA Approval
P
06
0007
ABBOTT ARCHITECT HBSAG AND ARCHITECT HBSAG CONFIRMATORY
3
PMA Approval
P
05
0051
ARCHITECT AUSAB
3
PMA Approval
P
06
0007
ARCHITECT HBSAG & ARCHITECT HBSAG CONFIRMATORY ASSAYS
3
PMA Approval
P
06
0007
ARCHITECT HBSAG & ARCHITECT HBSAG CONFIRMATORY ASSAYS
3
PMA Approval
P
06
0007
ARCHITECT HBSAG & ARCHITECT HBSAG CONFIRMATORY ASSAYS
3
PMA Approval
P
06
0007
ARCHITECT HBSAG & ARCHITECT HBSAG CONFIRMATORY ASSAYS
3
PMA Approval
P
05
0051
ABBOTT ARCHITECT AUSAB
3
PMA Approval
P
06
0007
ARCHITECT HBSAG/CONFIRMATORY
3
PMA Approval
P
05
0051
ARCHITECT AUSAB
3
PMA Approval
P
08
0023
ARCHITECT CORE
3
PMA Approval
P
06
0035
ARCHITECT CORE-M
3
PMA Approval
P
03
0029
ADVIA CENTAUR ANTI-HBS ASSAY
3
PMA Approval
P
00
0014
VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBS REAGENT PACK & CALIBRATOR
3
PMA Approval
P
03
0024
VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC REAGENT PACK AND CALIBRATOR
3
PMA Approval
P
06
0035
ARCHITECT CORE-M
3
PMA Approval
P
08
0023
ARCHITECT CORE
3
PMA Approval
P
05
0051
ARCHITECT AUSAB
3
PMA Approval
P
06
0007
ARCHITECT HBSAG/CONFIRMATORY
3
PMA Approval
P
99
0042
ETI-MAX 3000 ANALYZER
3
PMA Approval
P
06
0035
ARCHITECT CORE-M
3
PMA Approval
P
08
0023
ARCHITECH CORE
3
PMA Approval
P
06
0031
BIO-RAD MONOLISA ANTI-HBC EIA
3
PMA Approval
P
06
0031
MONOLISA ANTI-HBC EIA
3
PMA Approval
P
05
0048
MONOLISA ANTI-HBS EIA AND MONOLISA ANTI-HBS CALIBRATOR KIT
3
PMA Approval
P
06
0034
MONOLISA ANTI-HBC IGM EIA
3
PMA Approval
P
03
0026
VITROS IMMUNDIAGNOSTIC PRODUCTS ANTI-HBC IGM REAGENT PACK & CALIBRATOR
3
PMA Approval
P
00
0014
VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBS REAGENT PACK & CALIBRATOR
3
PMA Approval
P
03
0024
VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC REAGENT PACK & CALIBRATOR
3
PMA Approval
P
00
0044
VITROS IMMUNODIAGNOSTICS HBSAG REAGENT PACK & CALIBRATOR
3
PMA Approval
P
06
0012
AXSYM CORE 2.0
3
PMA Approval
P
06
0012
AXSYM CORE 2.0 (LN 8B88)
3
PMA Approval
P
06
0009
AXSYM CORE-M 2.0 (LN 8B89)
3
PMA Approval
P
05
0049
AXSYM HBSAG/CONFIRMATORY (LN 9B01)
3
PMA Approval
P
06
0003
AXSYM AUSAB (LN 3C74)
3
PMA Approval
P
03
0029
ADVIA ANTI-HBS ASSAY
3
PMA Approval
P
05
0048
BIO-RAD MONOLISA ANTI -HBS EIA
3
PMA Approval
P
03
0029
ADVIA CENTAUR ANTI-HBS (AHBS)
3
PMA Approval
P
00
0044
VITROS IMMUNODIAGNOSTIC PRODUCTS HBSAG REAGENT PACK AND CALIBRATOR; HBSAG CONFIRMATORY KIT
3
PMA Approval
P
00
0014
VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBS REAGENT PACK & CALIBRATOR
3
PMA Approval
P
06
0034
BIO-RAD MONOLISA ANTI-HBC IGM EIA
3
PMA Approval
P
00
0044
HBSAG REAGENT PACK/CALIBRATOR & CONFIRMATORY KIT
3
PMA Approval
P
03
0026
ANTI-HBC REAGENT PACK AND CALIBRATOR
3
PMA Approval
P
03
0024
ANTI-HBC REAGENT PACK AND CALIBRATOR
3
PMA Approval
P
00
0014
VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBS QUANTITATIVE REAGENT PACK AND CALIBRATOR
3
PMA Approval
P
01
0054
ELECSYS ANTI-HBS CALCHECK
3
PMA Approval
P
06
0012
AXSYM CORE 2.0
3
PMA Approval
P
99
0041
ETI-AB-EBK PLUS KIT
3
PMA Approval
P
99
0038
ETI-MAK-2PLUS & ETI-MAK-2 PLUS HBSAG CONFIRMATORY TEST KIT
3
PMA Approval
P
99
0044
ETI-COREK-IGMK PLUS KIT
3
PMA Approval
P
99
0043
ETI-EBK PLUS KIT
3
PMA Approval
P
99
0045
ETI-AB-COREK PLUS KIT
3
PMA Approval
P
99
0042
ETI-AB-AUK PLUS KIT
3
PMA Approval
P
03
0049
ADVIA CENTAUR HBSAG ASSAY
3
PMA Approval
P
03
0040
ADVIA CENTAUR HBC IGM ASSAY
3
PMA Approval
P
05
0048
BIO-RAD MONOLISA ANTI-HBS EIA
3
PMA Approval
P
04
0004
ADVIA CENTAUR HBC TOTAL ASSAY
3
PMA Approval
P
01
0051
IMMULITE/IMMULITE 1000 & IMMULITE 2000 ANTI-HBC
3
PMA Approval
P
01
0050
IMMULITE/IMMULITE 1000 & IMMULITE 2000 HBSAG & IMMULITE/IMMULITE 1000/IMMULITE 2000 HBSAG CONFIRMATORY
3
PMA Approval
P
01
0053
IMMULITE/IMMULITE 1000 & IMMULITE 2000 ANTI-HBC IGM
3
PMA Approval
P
01
0052
IMMULITE/IMMULITE 1000 & IMMULITE 2000 ANTI-HBS
3
PMA Approval
P
99
0045
ETI-AB-COREK PLUS ASSAY
3
PMA Approval
P
99
0041
ETI-AB-EBK PLUS ASSAY
3
PMA Approval
P
99
0043
ETI-EBK PLUS ASSAY
3
PMA Approval
P
99
0044
ETI-CORE-IGMK PLUS ASSAY
3
PMA Approval
P
99
0038
ETI-MAK-2 PLUS ASSAY
3
PMA Approval
P
00
0014
VITROS IMMUNDIAGNOSTICS PRODUCTS ANTI-HBS REAGENT PACK & CALIBRATOR
3
PMA Approval
P
01
0054
ELECSYS ANTI-HBS TEST SYSTEM
3
PMA Approval
P
01
0052
IMMULITE/IMMULITE 1000 AND IMMULITE 2000 ANTI-HBS ASSAYS
3
PMA Approval
P
08
0023
ABBOTT ARCHITECT CORE ASSAY
3
PMA Approval
P
00
0044
VITROS IMMUNODIAGNOSTIC PRODUCT HBSAG REAGENT PACK & CALIBRATOR & VITROS IMMUNODIAGNOSTIC PRODUCTS HBSAG CONFIRMATORY KI
3
PMA Approval
P
00
0044
VITROS IMMUNODIAGNOSTIC PRODUCTS HBSAG REAGENT PACK & CALIBRATOR & CONFIRMATORY KIT
3
PMA Approval
P
04
0004
ADVIA CENTAUR HBC TOTAL READYPACK REAGENTS AND ADVIA CENTAUR HBC TOTAL QUALITY CONTROL MATERIALS
3
PMA Approval
P
03
0040
ADVIA CENTAUR HBC IGM READYPACK REAGENTS AND ADVIA CENTAUR HBC IGM QUALITY CONTROL MATERIALS
3
PMA Approval
P
03
0049
ADVIA CENTAUR HBSAG & CONFIRMATORY ASSAYS
3
PMA Approval
P
03
0029
ADVIA CENTAUR AHBS ASSAY
3
PMA Approval
P
03
0024
VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC REAGENT PACK & CALIBRATOR
3
PMA Approval
P
03
0040
ADVIA CENTAUR ANTI-HBC IGM
3
PMA Approval
P
03
0049
ADVIA CENTAUR HBSAG (HBS) AND HBSAG CONFIRMATORY
3
PMA Approval
P
03
0029
ADVIA CENTAUR SOFTWARE V4.0 SP1 ANTI - HBS
3
PMA Approval
P
04
0004
ADVIA CENTAUR SOFTWARE V4.0 SP1 ANTI-HBCT
3
PMA Approval
P
03
0040
ADVIA CENTAUR XP SOFTWARE V6.0 ANTI-HBC IGM
3
PMA Approval
P
03
0029
ADVIA CENTAUR XP SOFTWARE V6.0 ANTI-HBS
3
PMA Approval
P
03
0049
ADVIA CENTAUR XP SOFTWARE V6.0 HBSAG & HBSAG CONFIRMATORY
3
PMA Approval
P
04
0004
ADVIA CENTAUR XP SOFTWARE V6.0 ANTI-HBCT
3
PMA Approval
P
03
0029
ADVIA CENTAUR AHBS
3
PMA Approval
P
05
0051
ARCHITECT AUSAB, ARCHITECT I1000 SYSTEM
3
PMA Approval
P
03
0026
VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC IGM REAGENT PACK AND CALIBRATOR
3
PMA Approval
P
06
0007
ABBOTT ARCHITECT HBSAG/ARCHITECT HBSAG CONFIRMATORY/ARCHITECT I1000SR SYSTEM
3
PMA Approval
P
06
0035
ABBOTT ARCHITECT CORE-M REAGENT KIT/CALIBRATORS/CONTROLS
3
PMA Approval
P
03
0026
VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC IGM REAGENT PACK & CALIBRATORS
3
PMA Approval
P
03
0029
ADVIA CENTAUR ANTI-HBS (AHBS)
3
PMA Approval
P
06
0007
ABBOTT ARCHITECT HBSAG
3
PMA Approval
P
01
0050
IMMULITE / IMMULITE 1000 HBSAG ASSAY AND IMMULITE 2000 HBSAG ASSAY
3
PMA Approval
P
03
0049
ADVIA CENTAUR HBSAG CONFIRMATORY ASSAY
3
PMA Approval
P
08
0023
ARCHITECT CORE REAGENT KIT, ARCHITECT CORE CALIBRATOR AND ARCHITECT CORE CONTROLS
3
PMA Approval
P
03
0049
ADVIA CENTAUR HBSAG READYPACK REAGENTS / CONFIRMATORY ASSAY/ QUALITY CONTROL MATERIAL
3
PMA Approval
P
04
0004
ADVIA CENTAUR HBC TOTAL READYPACK REAGENTS/TOTAL QUALITY CONTROL MATERIALS
3
PMA Approval
P
03
0040
ADVIA CENTAUR HBC IGM READYPACK REAGENTS/QUALITY CONTROL MATERIALS
3
PMA Approval
P
03
0029
ADVIA CENTAUR ANTI-HBS READYPACK REAGENTS & CALIBRATORS & CONTROL MATERIAL
3
PMA Approval
P
03
0026
VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC IGM REAGENT PACK & CALIBRATORS
3
PMA Approval
P
00
0014
VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBS QUANTITATIVE REAGENT PACK & CALIBRATORS
3
PMA Approval
P
03
0024
VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC REAGENT PACK & CALIBRATORS
3
PMA Approval
P
00
0044
VITROS IMMUNODIAGNOSTIC PRODUCTS HBSAG REAGENT PACK & CALIBRATORS
3
PMA Approval
P
06
0003
ABBOTT AXSYM AUSAB
3
PMA Approval
P
03
0049
ADVIA CENTAUR HBSAG
3
PMA Approval
P
04
0004
ADVIA CENTAUR HBCT
3
PMA Approval
P
03
0040
ADVIA CENTAUR HBCIGM
3
PMA Approval
P
06
0031
BIO-RAD MONOLISA ANTI-HBC EIA
3
PMA Approval
P
99
0043
ETI-EBK PLUS KIT
3
PMA Approval
P
99
0041
ETI-AB-EBK PLUS KIT
3
PMA Approval
P
06
0034
BIO-RAD MONOLISA ANTI-HBC IGM EIA
3
PMA Approval
P
01
0050
IMMULITE & IMMULITE 2000 HBSAG ASSAY
3
PMA Approval
P
00
0044
VITROS IMMUNODIAGNOSTIC PRODUCTS HBSAG REAGENT PACK & CALIBRATOR
3
PMA Approval
P
00
0014
VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBS REAGENT PACK & CALIBRATOR
3
PMA Approval
P
03
0026
VITROS IMMUNODIAGNOSTICS PRODUCTS ANTI-HBC IGM REAGENT PACK & CALIBRATOR
3
PMA Approval
P
03
0024
VITROS IMMUNODIAGNOSTICS PRODUCTS ANTI-HBC REAGENT PACK & CALIBRATOR
3
PMA Approval
P
05
0049
AXSYM HBSAG, AXSYM HBSAG CONFIRMATORY AND AXSYM HBSAG CONTROLS
3
PMA Approval
P
01
0052
IMMULITE/IMMULITE 1000 AND IMMULITE 2000 ANTI-HBS
3
PMA Approval
P
01
0053
IMMULITE/IMMULITE 1000 AND IMMULITE 2000 ANTI-HBC IGM
3
PMA Approval
P
01
0051
IMMULITE/IMMULITE 1000 AND IMMULITE 2000 ANTI-HBC
3
PMA Approval
P
01
0050
IMMULITE/IMMULITE 1000, IMMULITE 2000 HBSAG/HBSAG CONFIMATORY
3
PMA Approval
P
05
0051
ABBOTT ARCHITECT AUSAB
3
PMA Approval
P
99
0012
ELECSYS HBSAG TEST SYSTEM
3
PMA Approval
P
01
0054
ELECSYS ANTI-HBS TEST SYSTEM
3
PMA Approval
P
01
0054
ELECSYS ANTI-HBS TEST SYSTEM
3
PMA Approval
P
99
0012
ELECSYS HBSAG TEST SYSTEM
3
PMA Approval
P
06
0031
BIO-RAD MONOLOSA ANTI-HBC EIA
3
PMA Approval
P
06
0034
BIO-RAD MONOLISA ANTI-HBC IGM EIA
3
PMA Approval
P
01
0054
ELECSYS ANTI-HBS IMMUNOASSAY
3
PMA Approval
P
99
0012
ELECSYS HBSAG IMMUNOASSAY
3
PMA Approval
P
05
0048
BIO-RAD MONOLISA ANTI-HBS EIA & ANTI-HBS CALIBRATOR KIT
3
PMA Approval
P
01
0054
ELECSYS ANTI-HBS CALCHECK
3
PMA Approval
P
00
0044
VITROS IMMUNODIAGNOSTIC PRODUCTS HBSAG REAGENT PACK & CALIBRATOR, HBSAG CONFIRMATORY ASSAY
3
PMA Approval
P
03
0026
VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC IGM REAGENT PACK & CALIBRATORS
3
PMA Approval
P
00
0014
VITROS IMMUNDIAGNOSTICS PRODUCTS ANTI HB-S QUANTITATIVE REAGENT PACK & CALIBRATORS
3
PMA Approval
P
03
0024
VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC REAGENT PACK & CALIBRATORS
3
PMA Approval
P
00
0044
VITROS IMMUNODIAGNOSTIC PRODUCTS HBSAG REAGENT PACK & CALIBRATOR
3
PMA Approval
P
03
0024
VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC REAGENT PACK AND CALIBRATOR
3
PMA Approval
P
05
0049
ABBOTT AXSYM HBSAG
3
PMA Approval
P
05
0051
ABBOTT ARCHITECT
3
PMA Approval
P
06
0035
ARCHITECT CORE-M REAGENT KIT/CALIBRATORS/CONTROLS
3
PMA Approval
P
03
0029
ADVIA CENTAUR ANTI-HBS READYPACK REAGENTS & CALIBRATORS
3
PMA Approval
P
03
0024
VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC REAGENT PACK & CALIBRATOR
3
PMA Approval
P
00
0014
VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBS REAGENT PACK & CALIBRATOR
3
PMA Approval
P
06
0034
BIO RAD MONOLISA ANTI-HBC IGM EIA
3
PMA Approval
P
06
0031
BIO-RAD MONOLISA ANTI-HBC EIA
3
PMA Approval
P
00
0044
VITROS IMMUNODIAGNOSTIC PRODUCTS HBSAG REAGENT PACK AND CALIBRATOR & CONFIRMATORY KIT
3
PMA Approval
P
03
0026
VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC IGM REAGENT PACK & CALIBRATOR
3
PMA Approval
P
00
0044
VITROS IMMUNODIAGNOSTIC PRODUCTS HBSAG REAGENT PACK & CALIBRATOR & CONFIRMATORY KIT
3
PMA Approval
P
01
0054
ELECSYS ANTI-HBS IMMUNOASSAY AND ELECSYS PRECICONTROL ANTI-HBS
3
PMA Approval
P
01
0054
ELECSYS ANTI-HBS IMMUNOASSAY AND ELECSYS PRECICONTROL ANTI-HBS
3
PMA Approval
P
99
0012
ROCHE ELECSYS HBSAG IMMUNOASSAY, ELECSYS HBSAG CONFORMATORY TEST AND PRECICONTROL HBSAG
3
PMA Approval
P
03
0026
VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC IGM REAGENT PACK & CALIBRATOR
3
PMA Approval
P
05
0049
ABBOTT AXSYM HBSAG ASSAY
3
PMA Approval
P
06
0003
AXSYM AUSAB
3
PMA Approval
P
06
0009
AXSYM CORE-M 2.0 & AXSYM CORE-M 2.0 CONTROLS
3
PMA Approval
P
06
0012
AXSYM CORE 2.0 & AXSYM CORE 2.0 CONTROLS
3
PMA Approval
P
99
0043
DIASORIN ETI-EBK PLUS
3
PMA Approval
P
99
0044
DIASORIN ETI-CORE-IGMK PLUS
3
PMA Approval
P
99
0041
DIASORIN ETI-AB-EBK PLUS
3
PMA Approval
P
06
0007
ARCHITECT HBSAG AND HBSAG CONFIRMATORY
3
PMA Approval
P
06
0003
ABBOTT AXSYM AUSAB
3
PMA Approval
P
03
0026
VITROS IMMUNODIAGNOSTIC PRODUCT ANTI-HBC IGM REAGENT PACK & CALIBRATOR
3
PMA Approval
P
06
0003
ABBOTT AXSYM AUSAB
3
PMA Approval
P
06
0012
AXSYM CORE 2.0 AND AXSYM CORE 2.0 CONTROLS
3
PMA Approval
P
06
0007
ARCHITECT HBSAG REAGENT KIT, CALIBRATORS, CONTROLS, CONFIRMATORY REAGENT KIT, CONFIRMATORY MANUAL DILUENT
3
PMA Approval
P
00
0044
VITROS IMMUNODIAGNOSTIC PRODUCTS HBSAG REAGENT PACK, CALIBRATOR, CONFIRMATORY KIT
3
PMA Approval
P
01
0050
IMMULITE / IMMULITE 1000 HBSAG & IMMULITE 2000 HBSAG
3
PMA Approval
P
06
0009
AXSYM CORE-M 2.0 AND AXSYM CORE-M 2.0 CONTROLS
3
PMA Approval
P
05
0048
MONOLISA ANTI-HBS EIA
3
PMA Approval
P
05
0051
ARCHITECT AUSAB REAGENT KIT, ARCHITECT AUSAB CALIBRATORS, ARCHITECT AUSAB CONTROLS
3
PMA Approval
P
06
0003
AXSYM, AUSAB
3
PMA Approval
P
01
0054
ELECSYS ANTI-HBS IMMUNOASSAY TEST SYSTEM
3
PMA Approval
P
00
0044
VITROS IMMUNODIAGNOSTIC HBSAG REAGENT PACK CALIBRATOR AND CONFIRMATORY KIT
3
PMA Approval
P
01
0054
ELECSYS AND HBS IMMUNOASSAY AND ELECSYS PRECICONTROL ANTI-HBS
3
PMA Approval
P
01
0051
IMMULITE/IMMULITE 1000 AND IMMULITE 2000 ANTI-HBC ASSAYS
3
PMA Approval
P
03
0026
VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC IGM REAGENT PACK AND CALIBRATOR
3
PMA Approval
P
03
0024
VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC REAGENT PACK AND CALIBRATOR
3
PMA Approval
P
00
0044
VITROS IMMUNODIAGNOSTIC PRODUCTS HBSAG REAGENT PACK AND CALIBRATOR & PRODUCTS HBSAG CONFIRMATORY KIT
3
PMA Approval
P
00
0014
VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBS REAGENT PACK AND CALIBRATOR
3
PMA Approval
P
05
0051
ABBOTT ARCHITECT AUSAB
3
PMA Approval
P
05
0049
AXSYM HBSAG, HBSAG CONFIRMATORY, AND AXSYM HBSAG CONTROLS
3
PMA Approval
P
99
0038
ETI-MAK-2 PLUS
3
PMA Approval
P
00
0044
VITROS IMMUNODIAGNOSTIC PRODUCTS HBSAG REAGENT PACK AND CALIBRATOR, AND HBSAG CONFIRMATORY KIT
3
PMA Approval
P
00
0014
IMMUNODIAGNOSTIC PRODUCTS ANTI-HBS REAGENT PACK AND CALIBRATOR
3
PMA Approval
P
00
0044
VITROS IMMUNODIAGNOSTIC PRODUCTS HBSAG REAGENT PACK AND CALIBRATOR
3
PMA Approval
P
03
0026
VITROS IMMUNODIAGNOSTIC PRODICTS ANTI-HBC IGM REAGENT PACK AND CALIBRATOR
3
PMA Approval
P
03
0024
VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC REAGENT PACK AND CALIBRATOR
3
PMA Approval
P
00
0044
VITROS IMMUNODIAGNOSTIC PRODUCTS HBSAG REAGENT PACK AND CALIBRATORS
3
PMA Approval
P
99
0012
ELECSYS HBSAG TEST SYSTEM
3
PMA Approval
P
01
0052
IMMULITE/IMMULITE 1000 AND IMMULITE 2000 ANTI-HBS
3
PMA Approval
P
01
0051
IMMULITE/IMMULITE 1000 AND IMMULITE 2000 ANTI-HBC
3
PMA Approval
P
01
0053
IMMULITE/IMMULITE 1000 AND IMMULITE 2000 ANTI-HBC IGM
3
PMA Approval
P
03
0026
VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC IGM REAGENT PACK AND CALIBRATOR
3
PMA Approval
P
01
0054
ELECSYS ANTI-HBS,ELECSYS PRECICONTROL ANTI-HBS
3
PMA Approval
P
00
0044
VITROS IMMUNODIAGNOSTIC PRODUCTS HBSAG REAGENT PACK & CALIBRATORS
3
PMA Approval
P
99
0012
ELECSYS HBSAG IMMUNOASSAY, ELECSYS HBSAG CONFIRMATORY TEST AND ELECSYS PRECICONTROL HBSAG
3
PMA Approval
P
99
0045
ETI-AB-COREK PLUS
3
PMA Approval
P
00
0044
VITROS IMMUNODIAGNOSTIC PRODUCTS HBSAG REAGENT PACK AND CALIBRATOR/CONFIRMATORY KIT
3
PMA Approval
P
03
0026
VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC IGM REAGENT PACK & CALIBRATORS
3
PMA Approval
P
99
0038
DIASORIN ETI-MAK-2PLUS
3
PMA Approval
P
99
0043
DIASORIN ETI-EBK PLUS
3
PMA Approval
P
99
0041
DIASORIN ETI-AB-EBK PLUS
3
PMA Approval
P
99
0044
DIASORIN ETI-CORE-IGMK PLUS
3
PMA Approval
P
03
0026
VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC IGM REAGENT PACK AND CALIBRATORS
3
PMA Approval
P
03
0049
ADVIA CENTAUR HBSAG READY PACK REAGENTS/CONFIRMATORY READY PACK REAGENTS/QUALITY CONTROL MATERIAL
3
PMA Approval
P
00
0014
VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBS REAGENT PACK AND CALIBRATORS
3
PMA Approval
P
03
0024
VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC REAGENT PACK AND CALIBRATOR
3
PMA Approval
P
00
0044
VITROS IMMUNODIAGNOSTIC PRODUCTS HBSAG REAGENT PACK AND CALIBRATOR AND THE VITROS IMMUNODIAGNOSTIC PRODUCTS HBSAG CONFIR
3
PMA Approval
P
03
0026
VITROS IMMUNODIAGNOSTICS PRODUCTS ANTI-HBC IGM REAGENT PACK AND CALIBRATORS
3
PMA Approval
P
00
0014
VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HB REAGENT PACK & CALIBRATORS
3
PMA Approval
P
03
0026
VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC IGM REAGENT PACK AND CALIBRATOR
3
PMA Approval
P
03
0026
VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC IGM REAGENT PACK AND CALIBRATORS
3
PMA Approval
P
04
0004
ADVIA CENTAUR HBC TOTAL READYPACK REAGENTS/ADVIA CENTAUR HBC TOTAL QUALITY CONTROL MATERIALS
3
PMA Approval
P
00
0044
VITROS IMMUNODIAGNOSTIC PRODUCTS HBSAG REAGENT PACK AND CALIBRATOR AND THE VITROS IMMUNODIAGNOSTIC PRODUCTS HBSAG CONFIR
3
PMA Approval
P
00
0044
VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBSAG REAGENT PACK AND CALIBRATOR
3
PMA Approval
P
03
0026
VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC IGM REAGENT PACK AND CALIBRATOR
3
PMA Approval
P
03
0024
VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC REAGENT PACK & CALIBRATOR
3
PMA Approval
P
00
0014
VITROS IMMUNODIAGNOSTIC ANTI-HBS REAGENT PACK AND CALIBRATOR
3
PMA Approval
P
00
0014
VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBS QUANTITATIVE REAGENT PACK, VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBS CALIBRATS
3
PMA Approval
P
03
0040
ADVIA CENTAUR HBC IGM READYPACK REAGENTS, ADVIA CENTAUR HBC IGM QUALITY CONTROL MATERIALS
3
PMA Approval
P
00
0014
VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBS REAGENT PACK AND CALIBRATORS
3
PMA Approval
P
03
0026
VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC IGM REAGENT PACK AND CALIBRATOR
3
PMA Approval
P
99
0038
DIASORIN ETI-MAK-2 PLUS
3
PMA Approval
P
00
0014
VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBS REAGENT PACK AND CALIBRATORS
3
PMA Approval
P
03
0029
ADVIA CENTAUR ANTI-HBS READYPACK REAGENTS AND CALIBRATORS
3
PMA Approval
P
99
0038
DIASORIN ETI-MAK-2-PLUS
3
PMA Approval
P
99
0038
DIASORIN ETI-MAK-2 PLUS
3
PMA Approval
P
99
0044
DIASORIN ETI-CORE-IGMK PLUS
3
PMA Approval
P
99
0045
DIASORIN ETI-AB-COREK PLUS
3
PMA Approval
P
99
0043
DIASORIN ETI-EBK PLUS
3
PMA Approval
P
99
0042
DIASORIN ETI-AB-AUK PLUS
3
PMA Approval
P
99
0041
DIASORIN ETI-AB-EBK PLUS
3
PMA Approval
P
03
0024
VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC REAGENT PACK AND CALIBRATOR
3
PMA Approval
P
99
0043
DIASORIN ETI-EBK PLUS
3
PMA Approval
P
99
0041
DIASORIN ETI-AB-EBK PLUS
3
PMA Approval
P
03
0026
VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC IGM REAGENT PAK/CALIBRATOR
3
PMA Approval
P
03
0024
VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC REAGENT PACK/CALIBRATOR
3
PMA Approval
P
99
0041
DIASORIN ETI-AB-EBK PLUS ASSAY
3
PMA Approval
P
99
0043
DIASORIN ETI-EBK PLUS ASSAY
3
PMA Approval
P
99
0045
DIASORIN ETI-AB-COREK PLUS ASSAY
3
PMA Approval
P
99
0038
DIASORIN ETI-MAK-2 PLUS ASSAY
3
PMA Approval
P
00
0014
VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBS REAGENT PACK AND CALIBRATORS
3
PMA Approval
P
99
0042
ETI-AB-AUK PLUS
3
PMA Approval
P
99
0043
ETI-EBK PLUS
3
PMA Approval
P
99
0044
ETI-CORE-IGMK PLUS
3
PMA Approval
P
99
0045
ETI-AB-COREK PLUS
3
PMA Approval
P
01
0050
IMMULITE/ IMMULITE 1000 AND IMMULITE 2000 HBSAG KITS.
3
PMA Approval
P
99
0041
ETI-AB-EBK PLUS
3
PMA Approval
P
99
0044
DIASORIN ETI-CORE-IGMK PLUS
3
PMA Approval
P
00
0044
VITROS IMMUNODIAGNOSTIC PRODUCTS HBSAG REAGENT PACK/ CALIBRATOR
3
PMA Approval
P
99
0038
DIASORIN HBSAG CONFIRMATORY TEST
3
PMA Approval
P
01
0052
IMMULITE, IMMULITE 1000 ANTI-HBS AND IMMULITE 2000 ANTI-HBS
3
PMA Approval
P
01
0050
IMMULITE,IMMULITE 1000 HBSAG,CONFIRMATORY AND IMMULITE 2000 HBSAG,CONFIRMATORY KIT
3
PMA Approval
P
01
0053
IMMULITE, IMMULITE 1000 ANTI-HBC AND IMMULITE 2000 ANTI-HBC
3
PMA Approval
P
01
0051
IMMULITE, IMMULITE 1000 ANTI-HBC IGM AND IMMULITE 2000 ANTI-HBCIGM
3
PMA Approval
P
00
0014
VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBS REAGENT/ANTI-HBS CALIBRATORS
3
PMA Approval
P
79
0025
ABBOTT HBE (RDNA) EIA
3
PMA Approval
P
99
0042
ETI-AB-AUK PLUS
3
PMA Approval
P
99
0042
ETI-AB-AUK PLUS ASSAY
3
PMA Approval
P
99
0041
DIASORIN ETI-AB-EBK PLUS
3
PMA Approval
P
99
0044
DIASORIN ETI-CORE-IGMK PLUS
3
PMA Approval
P
99
0045
ETI-AB-COREK PLUS
3
PMA Approval
P
99
0043
DIASORIN ETI-EBK PLUS
3
PMA Approval
P
99
0038
DIASORIN ETI-MAK-2 PLUS
3
PMA Approval
P
01
0050
IMMULITE 2000 XPI HBSAG
3
PMA Approval
P
01
0053
IMMULITE 2000 XPI ANTI-HBC IMG
3
PMA Approval
P
01
0051
IMMULITE 2000 XPI ANTI-HBC
3
PMA Approval
P
01
0052
IMMULITE 2000 XPI ANTI-HBS
3
PMA Approval
P
99
0042
DIASORIN ETI-AB-AUK PLUS ASSAY
3
PMA Approval
P
99
0043
ETI-EBK PLUS
3
PMA Approval
P
99
0041
DIASORIN ETI-AB-EBK PLUS
3
PMA Approval
P
99
0045
ETI-AB-COREK PLUS
3
PMA Approval
P
99
0038
ETI-MAK-2 PLUS
3
PMA Approval
P
99
0044
ETI-CORE-IGMK PLUS
3
PMA Approval
P
99
0042
ETI-AB-AUK PLUS
3
PMA Approval
P
01
0054
ELECSYS ANTI-HBS
3
PMA Approval
P
99
0042
ETI-AB-AUK PLUS ASSAY
3
PMA Approval
P
00
0014
VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBS REAGENT PACK/CALIBRATORS
3
PMA Approval
P
00
0044
VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBSAG REAGENT PACK, CALIBRATORS, AND CONFIRMATORY KIT
3
PMA Approval
P
99
0012
ELECSYS HBSAG IMMUNOASSAY, ELECSYS HBSAG CONFIRMATORY, AND PRECICONTROL HBSAG
3
PMA Approval
P
00
0044
VITROS IMMUNODIAGNOSTIC PRODUCTS HBS AG REAGENT PACK/CALIBRATOR/CONFIRMATORY KIT
3
PMA Approval
P
00
0044
VITROS IMMUNODIAGNOSTIC PRODUCTS/HBSAG REAGENT PACK,VITROS IMMUNODIAGNOSTIC PRODUCTS CONFIRMATORY KIT, AND VITROS IMMUNR
3
PMA Approval
P
00
0014
VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBS REAGENT PACK & CALIBRATORS
3
PMA Approval
P
00
0014
VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBS REAGENT PACK & CALIBRATORS
3
PMA Approval
P
99
0042
DIASORIN ETI-AB-AUK PLUS ASSAY
3
PMA Approval
P
99
0038
DIASORIN ETI MAK-2 PLUS ASSAY
3
PMA Approval
P
00
0014
VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBS REAGENT PACK/CALIBRATORS
3
PMA Approval
P
99
0043
DIASORIN ETI-EBK PLUS ASSAY
3
PMA Approval
P
87
0048
EBK RIA ASSAY/ETI-EBK
3
PMA Approval
P
00
0014
VITROS IMMUNODIAGNOSTIC PRODUCTS:ANTI-HBS REAGENT PACK/ANTI-HBS CALIBRATORS
3
PMA Approval
P
79
0025
ABBOTT HBE (RDNA) EIA
3
PMA Approval
P
79
0025
ABBOTT HBE (RDNA) EIA TEST KIT
3
PMA Approval
P
87
0048
EBK
3
PMA Approval
P
87
0048
EBK
3
PMA Approval
P
84
0070
HEPANOSTIKA(TM) HBEAG/ANTI HBE MICROELISA(TM) SYST
3
PMA Approval
P
85
0044
AB-CORE K HEPATITIS B CORE ANTIGEN 125I
3
PMA Approval
P
79
0025
ABBOTT HBE DIAGNOSTIC KIT
3
PMA Approval
P
85
0044
AB-CORE K HEPATITIS B CORE ANTIGEN 125I
3
PMA Approval
P
85
0044
AB-CORE K HEPATITIS B CORE ANTIGEN 125I
3
PMA Approval
P
84
0070
HEPANOSTIKA(TM) HBEAG/ANTI HBE MICROELISA(TM) SYST
3
PMA Approval
P
78
0016
CORAB
3
PMA Approval
P
83
0014
CORAB-M
3
PMA Approval
P
78
0016
CORAB
3
PMA Approval
P
79
0025
HBE RIA DIAGNOSTIC KIT
3
PMA Approval
P
79
0025
ABBOTT HBE DIAGNOSTIC KIT
3
PMA Approval
P
79
0025
ABBOTT HBE DIAGNOSTIC KIT
3
PMA Approval
P
78
0016
CORAB
3
PMA Approval
P
78
0016
CORAB
3
PMA Approval
LQI
Hepatitis Delta Serological Reagents
3
Product Code
MAQ
Kit, Dna Detection, Human Papillomavirus
3
Product Code
MHR
Test, Anti-Tumor Cell Susceptibility
3
Product Code
MKT
Hepatitis Viral B Dna Detection
3
Product Code
MYL
Assay,Enzyme Linked Immunosorbent,Parvovirus B19 Igg
3
Product Code
MYM
Assay,Enzyme Linked Immunosorbent,Parvovirus B19 Igm
3
Product Code
MZO
Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus
3
Product Code
OIH
Yersinia Spp. Reagents
U
Product Code
OJN
Mycobacterium Tuberculosis, Cell Mediated Immune Response, Enzyme-Linked Immunospot Test
3
Product Code
OJO
Enzyme Linked Immunosorbent Assay For The Detection Of Lipoarabinomannan Antigen Of Mycobacteria
N
Product Code
ORL
Whole Blood Pre-Treatment T-Cell Enrichment Reagent
3
Product Code
OTT
Research Use Only/Microbiology
N
Product Code
OYB
Kit, Rna Detection, Human Papillomavirus
3
Product Code
PAB
Cytomegalovirus (Cmv) Dna Quantitative Assay
3
Product Code
PCY
Investigational Use Only - Microbiology
N
Product Code
POA
Reagents, Zika Virus Nucleic Acid
N
Product Code
POG
Reagents, Ebola Zaire Virus (Detected In The West Africa Outbreak In 2014) Nucleic Acid
N
Product Code
PYS
Zika Virus Serological Reagents (Emergency Use)
N
Product Code
QHV
Multiple Osteoarticular Pathogen Antigen Kit
N
Product Code
QIM
Bartonella Spp. Serological Reagents
N
Product Code
QIN
Babesia Spp. Serological Reagents
N
Product Code
QIO
Anaplasma Spp. And Ehrlichia Spp. Serological Reagents
N
Product Code
QIP
Rickettsia Spp. (Spotted Fever Group Or Typhus Group) Serological Reagents
N
Product Code
QIQ
Orientia Spp. (Scrub Typhus) Serological Reagents
N
Product Code
QJR
Reagents, 2019-Novel Coronavirus Nucleic Acid
N
Product Code
QKO
Reagent, Coronavirus Serological
N
Product Code
QKP
Coronavirus Antigen Detection Test System.
N
Product Code
QLT
Covid-19 Multi-Analyte Respiratory Panel Nucleic Acid Devices
N
Product Code
QLW
Covid-19 Test Home Collection Kit Devices
N
Product Code
QMN
Covid-19 Multi-Analyte Antigen Device
N
Product Code
QSH
Coronavirus Marker Detection
N
Product Code
QSN
Orthopedic Infection Microbial Multiplex Nucleic Acid Detection System
2
Product Code
QSS
Hiv Self-Tests
3
Product Code
QTA
Ngs Whole Genome Sequencing For Sars-Cov-2 Genetic Analysis
N
Product Code
QTP
Reagents, Monkeypox Virus Nucleic Acid.
N
Product Code
QTQ
Reagents, Non-Variola Orthopoxvirus Nucleic Acid.
N
Product Code
QWB
Over-The-Counter Molecular Test To Detect Sars-Cov-2 From Clinical Specimens
2
Product Code
QVR
Multiplex Nucleic Acid Detection System For Biothreat Agents
2
Product Code
QUU
Simple In Vitro Diagnostic Device For The Detection Of Secreted Proteins From Bacillus Spp. In Human Clinical Samples
2
Product Code
QVF
Simple Point-Of-Care Device To Directly Detect Sars-Cov-2 Viral Targets From Clinical Specimens In Near-Patient Settings
2
Product Code
QVP
Sars-Cov-2 Serology Test
2
Product Code
QWR
Simple Point-Of-Care Device To Detect Sar-Cov-2 Nucleic Acid Targets From Clinical Specimens In Near-Patient Settings
2
Product Code
QXA
Lateral Flow Immunochromatography Assay For Host Biomarkers Of Respiratory Infection
2
Product Code
QYA
System For Detection Of Nucleic Acid From Non-Viral Microorganism(S) Causing Stis Using Specimens Collected At Home
2
Product Code
QYT
Over-The-Counter Covid-19 Antigen Test
2
Product Code
QZX
Positive Blood Culture Processor For Inoculum Preparation Used For Antimicrobial Susceptibility Testing
2
Product Code
SAN
Automated Antimicrobial Susceptibility Test System For Positive Blood Culture Samples
2
Product Code
SBP
Simple Point-Of-Care Nucleic Acid-Based Hepatitis C Virus Ribonucleic Acid Test
2
Product Code
SBT
Device To Detect Microbial Colonization Directly From Clinical Specimens.
2
Product Code
SBZ
Test For Detection Of Antibodies Associated With Syphilis Performed By Lay Users
2
Product Code
SCA
Multi-Analyte Respiratory Virus Antigen Detection Test
2
Product Code
SDM
Nucleic Acid Test Used For Screening Of Cadaveric (Non-Heart-Beating) Donors Of Blood Or Blood Products Or Hct/Ps
U
Product Code
SDN
Serology Test Used For Screening Of Cadaveric (Non-Heart-Beating) Donors Of Blood Or Blood Products Or Hct/Ps
U
Product Code
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Last synced on 6 December 2024 at 11:05 pm
MI
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MI-misc
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P990012
View Source
Elecsys HBsAg Immunoassay
Page Type
PMA Approval
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
Applicant
ROCHE DIAGNOSTICS CORP.
Trade Name
ELECSYS HBSAG IMMUNOASSAY, ELECSYS HBSAG CONFIRMATORY, AND PRECICONTROL HBSAG
Generic Name
Test, hepatitis b (b core, be antigen, be antibody, b core igm)
Decision Date
6/1/2001
Days to Decision
820 days
Decision Code
APWD
FDA Decision
Withdrawal after approval
FDA Browser
by
Innolitics
Anesthesiology
Cardiovascular
Chemistry
Dental
Ear, Nose, Throat
Gastroenterology and Urology
General Hospital
Hematology
Immunology
Microbiology
Miscellaneous
QGN
Lateral Flow Immunochromatography Assay For Host Infection Biomarkers
PBK
Non-Variola Orthopoxvirus Real-Time Pcr Primer And Probe Set
OBF
Assay, Genotyping, Hepatitis C Virus
PGH
Hsv-1 And Hsv-2 Cns Nucleic-Acid Based Panel
QHM
Serology Tests Used For Infectious Disease Screening Of Blood And Plasma Donations
PQA
Vaginitis And Bacterial Vaginosis Nucleic Acid Detection System
PRA
Variola Virus Nucleic Acid-Based Detection Assay
PRH
Positive Blood Culture Identification And Ast Kit
PVQ
Rickettsia Spp. Nucleic Acid Based Detection Assay
PYN
Fish (Fluorescence In Situ Hybridization) Kit, Nucleic Acid, Plasmodium Sp.
QAA
Coccidioides Spp. Nucleic Acid Detection System For Respiratory Specimens
QBD
Microbial Nucleic Acid Storage And Stabilization Device
QBN
Mass Spectrometry, Maldi Tof, Microorganism Identification, Cultured Isolates
QDZ
Qualitative Cytomegalovirus Nucleic Acid-Based Detection Device For Congenital Cytomegalovirus Infection
QEP
Nucleic Acid Detection System For Non-Viral Microorganism(S) Causing Sexually Transmitted Infections
QFA
Assay For Detection Of Proteases In Chronic Wounds
QFO
Zika Virus Serological Reagents
QHO
Nucleic-Acid Tests Used For Infectious Disease Screening Of Blood And Plasma Donations
QID
Device To Detect Antigens Of Biothreat Microbial Agents In Human Clinical Specimens
QNJ
Mass Spectrometry, Microorganism Identification, Blood Culture
MZP
Assay, Hybridization And/Or Nucleic Acid Amplification For Detection Of Hepatitis C Rna,Hepatitis C Virus
NCD
Test, Immunity, Cell Mediated, Mycobacterium Tuberculosis
NWY
Test, Qualitative, Detection Of Dengue Igm And Igg Antibodies
QPO
Device To Preserve And Stabilize Relative Abundances Of Microbial Nucleic Acids In Clinical Samples
QQV
Automated System For Sample Preparation And Identification Of Microorganisms From Cultured Isolates By Mass Spectrometry
PZF
Mers-Cov And Common Respiratory Pathogens Multiplex Nucleic Acid Detection System
QDS
Mers-Cov And Common Respiratory Pathogens Semi-Quantitative And Quantitative Multiplex Nucleic Acid Detection System
LOM
Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)
P
21
0003
ARCHITECT HBsAg Next Qualitative Reagent Kit, ARCHITECT HBsAg Next Confirmatory Reagent Kit, ARCHITECT HBsAg NEXT Qualit
P
21
0019
ADVIA Centaur Anti-HBc Total (HBcT2) and Atellica IM Anti-HBc Total (HBcT2)
P
20
0017
ADVIA Centaur Anti-HBe2 (aHBe2) assay
P
19
0034
Elecsys Anti-HBs II, PreciControl Anti-HBs, Anti-HBs CalCheck
P
19
0005
Elecsys Anti-HBe, PreciControl Anti-HBe
P
19
0017
LIAISON® XL MUREX HBsAg Qual, LIAISON® MUREX Control HBsAg, and LIAISON® XL MUREX HBsAg Confirmatory Test
P
18
0049
LIAISON® XL MUREX anti-HBe, LIAISON® XL MUREX Control anti-HBe
P
18
0048
LIAISON® XL MUREX HBeAg, LIAISON® XL MUREX Control HBeAg
P
18
0045
LIAISON® XL MUREX HBc IgM, LIAISON® XL MUREX Control HBc IgM
P
18
0039
LIAISON® XL MUREX Anti-HBs, LIAISON® XL MUREX Control Anti-HBs and LIAISON® XL MUREX Anti-HBs Verifiers
P
18
0045
LIAISON® XL Murex HBc IgM and LIAISON® XL Murex Control HBc IgM
P
18
0039
LIAISON® XL Murex Anti-HBs, LIAISON® XL Murex Control Anti-HBs and LIAISON® XL Murex Anti-HBs Verifiers
P
18
0038
LIAISON® XL Murex Anti-HBc and LIAISON® XL Murex Control Anti-HBc
P
18
0049
LIAISON® XL Murex Anti-HBe and LIAISON® XL Murex Control Anti-HBe
P
18
0048
LIAISON® XL Murex HBeAg and LIAISON® XL Murex Control HBeAg
P
99
0042
ETI-AB-AUK PLUS assay
P
18
0039
LIAISON® XL Murex Anti-HBs, LIAISON® XL Murex Control Anti-HBs and LIAISON® XL Murex Anti-HBs Verifiers
P
99
0043
ETI-EBK PLUS assay
P
99
0038
ETI-MAK-2 PLUS and HBsAg Confirmatory Test assay
P
18
0049
LIAISON® XL MUREX Anti-HBe and LIAISON® XL MUREX Control Anti-HBe
P
18
0045
LIAISON® XL MUREX HBc IgM and LIAISON® XL MUREX Control HBc IgM
P
18
0038
LIAISON® XL Murex Anti-HBc and LIAISON® XL Murex Control Anti-HBc
P
18
0048
LIAISON® XL MUREX HBeAg and LIAISON® XL MUREX Control HBeAg
P
18
0039
LIAISON® XL MUREX Anti-HBs, LIAISON® XL MUREX Control Anti-HBs and LIAISON® XL Murex Anti-HBs Verifiers
P
18
0045
LIAISON® XL MUREX HBc IgM and LIAISON® XL MUREX Control HBc IgM
P
18
0038
LIAISON® XL MUREX anti-HBc and LIAISON® XL MUREX Control anti-HBc
P
18
0048
LIAISON® XL MUREX HBeAg and LIAISON® XL MUREX Control HBeAg
P
18
0049
LIAISON® XL MUREX Anti-HBe and LIAISON® XL MUREX Control Anti-HBe
P
19
0034
Elecsys Anti-HBs II
P
16
0019
Elecsys HBsAg II
P
01
0054
Elecsys Anti-HBs
P
06
0035
ARCHITECT CORE-M / Alinity i Anti-HBc IgM
P
08
0023
ARCHITECT CORE / Alinity i Anti-HBc
P
11
0029
ARCHITECT HBsAg Qualitative/Confirmatory / Alinity i HBsAg Qualitative II/Confirmatory
P
05
0051
ARCHITECT AUSAB / Alinity i Anti-HBs
P
16
0019
Elecsys HBsAg Confirmatory Test
P
05
0051
ARCHITECT AUSAB (LN 1L82)
P
06
0035
ARCHITECT CORE-M (LN 6L23)
P
11
0029
ARCHITECT HBsAg Qualitative (LN 4P53), ARCHITECT HBsAg Qualitative Confirmatory (LN 4P54)
P
08
0023
ARCHITECT CORE (LN 6L22)
P
19
0005
Elecsys Anti-HBe, PreciControl Anti-HBe
P
05
0051
Abbott ARCHITECT AUSAB Reagent (100 Test), Abbott ARCHITECT AUSAB Reagent (500 Test), Abbott ARCHITECT AUSAB Reagent, Al
P
18
0039
LIAISON XL MUREX Anti-HBs, LIAISON XL MUREX Control Anti-HBs and LIAISON XL MUREX Anti-HBs Verifiers
P
19
0017
LIAISON XL MUREX HBsAg Qual, LIAISON XL MUREX Control HBsAg Qual
P
18
0048
LIAISON XL MUREX HBeAg, LIAISON XL MUREX Control HBeAg
P
18
0049
LIAISON XL MUREX Anti-HBe, LIAISON XL MUREX Control Anti-HBe
P
18
0038
LIAISON XL MUREX Anti-HBc, LIAISON XL MUREX Control Anti-HBc
P
18
0045
LIAISON XL MUREX HBc IgM, LIAISON XL MUREX Control HBc IgM
P
20
0017
ADVIA Centaur Anti-HBe2 (aHBe2) assay
P
01
0050
IMMULITE 2000 HBs Ag Confirmatory
P
06
0035
ARCHITECT CORE-M Reagent Kit, Alinity i Anti-HBc IgM Reagent Kit
P
03
0040
Atellica IM Hepatitis B core IgM (aHBcM) Assay
P
04
0004
Atellica IM Anti-Hepatitis B core Total (HBcT) Assay
P
09
0024
Atellica IM Hepatitis B e Antigen (HBeAg) Assay
P
10
0039
Atellica IM Anti-Hepatitis B surface Antigen 2 (aHBs2) Assay
P
11
0041
Atellica IM Hepatitis B surface Antigen II (HBsll), Atellica IM Hepatitis B surface Antigen 11 Confirmatory (HBsll Conf)
P
05
0051
ARCHITECT AUSAB Reagent, ARCHITECT AUSAB Reagent Kit, Alinity i Anti-HBs Reagent Kit
P
08
0023
ARCHITECT CORE Reagent Kit, Alinity i Anti-HBc Reagent Kit
P
11
0029
ARCHITECT HBsAg Qualitative Reagent, ARCHITECT HBsAg Qualitative Confirmatory Reagent, Alinity i HBsAg Qualitative II Re
P
06
0035
ARCHITECT CORE-M Reagent Kit, Alinity i Anti-HBc IgM Reagent Kit
P
10
0039
ADVIA Centaur aHBs2 Assay
P
03
0049
ADVIA Centaur HBsAg ReadyPack Reagents/ADVIA Centaur HBsAg Confirmatory ReadyPack Reagents, ADVIA Centaur HBsAg Quality
P
11
0041
ADVIA Centaur HBsAg II(HBsII), ADVIA Centaur HBsAg Confirmatory, ADVIA Centaur HBsAg Quality Control Material, Atellica
P
04
0004
ADVIA Centaur HBc Total ReadyPack Reagents, ADVIA Centaur HBc Total Quality Control Materials, Atellica IM Anti-Hepatiti
P
01
0051
IMMULITE 2000/2000 XPi Anti-HBc
P
10
0039
ADVIA Centaur anti-HBs2 (aHBs2), ADVIA Centaur Anti-HBs2 (aHBs2) Quality Control Material, Atellica IM Anti-Hepatitis B
P
03
0040
ADVIA Centaur Hepatitis B Core Antigen (aHBcM) Assay, Atellica IM Hepatitis B Core Antigen (aHBcM) Assay, Atellica IM He
P
01
0053
IMMULITE 2000/2000 XPi Anti-HBc IgM
P
19
0034
Elecsys Anti-HBs II, PreciControl Anti-HBs, Anti-HBs CalCheck
P
19
0005
Elecsys Anti-HBe, PreciControl Anti-HBe
P
05
0051
ARCHITECT AUSAB and Alinity i Anti-HBs
P
00
0014
VITROS Immunodiagnostic Products Anti-HBs Quantitative Reagent Pack and Calibrator
P
16
0019
Elecsys HBsAg II Auto Confirm
P
01
0053
IMMULITE 2000 Anti-HBcM
P
01
0051
IMMULITE 2000 Anti-HBc
P
01
0050
IMMULITE 2000 HBsAg Confirmatory
P
01
0052
IMMULITE 2000 Anti-HBs
P
19
0017
LIAISON® XL MUREX HBsAg Qual, LIAISON® MUREX Control HBsAg, and LIAISON® XL MUREX HBsAg Confirmatory Test
P
18
0049
LIAISON® XL MUREX anti-HBe, LIAISON® XL MUREX Control anti-HBe
P
18
0048
LIAISON® XL MUREX HBeAg, LIAISON® XL MUREX Control HBeAg
P
18
0045
LIAISON® XL MUREX HBc IgM, LIAISON® XL MUREX Control HBc IgM
P
11
0041
ADVIA Centaur HBsAgII/Confirmatory Readypack Reagents and QC Material
P
03
0049
ADVIA Centaur HBsAg/Confirmatory Readypack Reagents, Calibrators and Controls
P
10
0039
ADVIA Centaur aHBs2 Readypack Reagents and Quality Control Materials
P
04
0004
ADVIA Centaur HBc Total Readypack Reagents and Quality COntrol Materials
P
03
0040
ADVIA Centaur HBc IgM Readypack Reagents and Quality Control Material
P
09
0024
ADVIA Centaur HBeAg Readypack Reagents and Quality Control Material
P
99
0043
ETI-EBK PLUS assay
P
99
0042
ETI-AB-AUK PLUS assay
P
18
0038
LIAISON XL Murex Anti-HBc and LIAISON XL Murex Control Anti-HBc
P
99
0038
ETI-MAK-2 PLUS and HBsAg Confirmatory Test assays
P
18
0039
LIAISON XL Murex Anti-HBs, LIAISON XL Murex Control Anti-HBs and LIAISON XL Murex Anti-HBs Verifiers
P
18
0038
LIAISON XL MUREX Anti-HBc
P
18
0039
LIAISON XL MUREX Anti-HBs
P
11
0029
ARCHITECT HBsAg Qualitative Reagent Kit, ARCHITECT HBsAg Qualitative Reagent Kit, ARCHITECT HBsAg Qualitative Confirmato
P
05
0051
Alinity i Anti-HBs Reagent Kit
P
06
0035
Alinity i Anti-HBc IgM Reagent Kit
P
08
0023
Alinity i Anti-HBc Reagent Kit
P
11
0029
Alinity i HBsAg Qualitative II Reagent Kit and Alinity i HBsAg Qualitative II Confirmatory Kit
P
11
0029
Alinity i HBsAg Qualitative II
P
05
0051
ARCHITECT AUSAB
P
11
0029
ARCHITECT HBsAg Qualitative/Confirmatory
P
06
0035
ARCHITECT CORE-M
P
08
0023
ARCHITECT CORE
P
08
0023
Alinity i Anti-HBc
P
05
0051
Alinity i Anti-HBs
P
06
0035
Alinity i Anti-HBc lgM
P
18
0038
LIAISON XL MUREX anti-HBc
P
03
0040
Atellica IM Hepatitis B core IgM (aHBcM) Assay
P
04
0004
Atellica IM Anti-Hepatitis B core Total (HBcT) Assay
P
09
0024
Atellica IM Hepatitis B e Antigen (HBeAg) Assay
P
10
0039
Atellica IM Anti-Hepatitis B surface Antigen 2 (aHBs2)Assay
P
11
0041
Atellica IM Hepatitis B surface Antigen II (HBs11) and Atellica IM Hepatitis B surface Antigen 11 confirmatory (HBs11 Co
P
11
0041
ADVIA Centaur and Atellica IM HBsAgII
P
09
0024
ADVIA Centaur and Atellica IM HBeAg
P
03
0049
ADVIA Centaur HBsAg
P
04
0004
ADVIA Centaur and Atellica IM HBc Total
P
10
0039
ADVIA Centaur and Atellica IM Anti-HBs2 (aHBs2)
P
03
0040
ADVIA Centaur and Atellica IM HBc IgM
P
16
0019
Elecsys HBsAg II, Elecsys HBsAg Confirmatory Test, and PreciControl HBsAg II
P
18
0039
LIAISON® XL MUREX Anti-HBs, LIAISON® XL MUREX Control Anti-HBs and LIAISON® XL MUREX Anti-HBs Verifiers
P
11
0029
Alinity i HBsAg Qualitative II, Alinity i HBsAg Qualitative Confirmatory
P
18
0038
LIAISON XL MUREX Anti-HBc, LIAISON MUREX Control Anti-HBc
P
01
0050
IMMULITE 2000 HBsAg & HBs Ag Confirmatory
P
01
0052
IMMULITE 2000 Anti-HBs
P
01
0051
IMMULITE 2000 Anti-HBc
P
01
0053
IMMULITE 2000 Anti HBc IgM
P
05
0051
ARCHITECT AUSAB, LN 1L82
P
03
0049
ADVIA Centaur HBsAg
P
99
0038
ETI MAK-2 PLUS Assay and HBsAg Confirmatory Test
P
99
0042
ETI-AB-AUK PLUS assay
P
99
0043
ETI-EBK PLUS Aassay
P
99
0043
ETI-EBK Plus Assay
P
99
0042
ETI-AB-AUK Plus Assay
P
99
0038
ETI-MAK-2 Plus Assay
P
05
0051
ARCHITECT AUSAB
P
06
0035
Alinity i Anti-HBc IgM Reagent Kit, Alinity i Anti-HBc IgM Calibrators, Alinity i Anti-HBc IgM Controls
P
10
0001
VITROS Anti-HBe
P
00
0044
VITROS HBsAg
P
09
0028
VITROS HBeAg
P
03
0026
VITROS Anti-HBc IgM
P
03
0024
VITROS Anti-HBc
P
00
0014
VITROS Anti-HBs
P
10
0032
Elecsys Anti-HBc II
P
11
0025
Elecsys Anti-HBc IgM
P
11
0031
Elecsys Anti-HBc IgM
P
01
0054
Elecsys Anti-HBs
P
11
0022
Elecsys Anti-HBc IgM
P
10
0031
Elecsys Anti-HBc II
P
99
0012
Elecsys HBsAg Immunoassay
P
16
0019
Elecsys HBsAg II
P
01
0054
Elecsys Anti-HBs; PreciControl Anti-HBs; Anti-HBs CalCheck
P
11
0041
Atellica IM Hepatitis B surface Antigen II (HBsII( and Atellica IM Hepatitis B surface Antigen 1 1 Comfirmatory *HBs11 C
P
09
0024
Atellica IM Hepatitis B e Antigen (HBeAg) Assay
P
04
0004
Atellica Im Anti-Hepatitis B core Total (HBcT) Assay
P
03
0040
Atellica IM Hepatitis B orfe IgM (aHBcM) Assay
P
10
0039
Atellica IM Anti-Hepatitis B surface Antigen 2 (aHBs2) Assay
P
08
0023
Alinity i Anti-HBc Reagent Kit, Alinity i Anti-HBc Calibrator, Alinity i Anti-HBc Controls
P
05
0051
Alinity i Anti-HBs Regent Kit, Alinity i Anti-HBs Calibrators, and Alinity i Anti-HBs Controls
P
03
0026
VITROS Immunodiagnostic Products Anti-HBc IgM Reagent Pack and Calibrator
P
03
0024
VITROS Immunodiagnostic Products Anti-HBc Reagent Pack and Calibrator
P
00
0044
VITROS Immunodiagnostic Products HBsAg Reagent Pack, Calibrator and Confirmatory Kit
P
00
0014
VITROS Immunodiagnostic Products Anti-HBs Quantitative Reagent Pack and Calibrator
P
10
0001
VITROS Immunodiagnostic Products Anti-HBe Reagent Pack and Calibrator
P
09
0028
VITROS Immunodiagnostic Products HBeAg Reagent Pack and Calibrator
P
06
0035
ARCHITECT CORE-M (LN 6l23), Calibrators, Controls and Reagent Kit
P
11
0029
ARCHITECT HBsAg Qualitative (LN 4P53) and HBsAg Qualitative Confirmatory (LN 4P54)
P
05
0051
ARCHITECT AUSAB (LN 1L82)
P
08
0023
ARCHITECT CORE (LN 6L22)
P
10
0032
Elecsys Anti-HBc II
P
11
0022
Elecsys Anti-HBc IgM
P
13
0015
Elecsys HBeAg
P
11
0025
Elecsys Anti-HBc IgM
P
11
0031
Elecsys Anti-HBc IgM
P
16
0019
Elecsys HBsAg II (100/200 tests)
P
01
0054
Elecsys ANti-HBs
P
10
0031
Elecsys Anti-HBc II
P
03
0024
VITROS Immunodiagnostic Products Anti-HBc Reagent Pack and Calibrator
P
04
0004
Atellica IM anti-HBc Total (HBcT)
P
11
0041
Atellica IM HBsAgII (HBsII)/Atellica IM HBsAg Confirmatory
P
10
0039
Atellica IM Anti-Hepatitis B Surface Antigen 2 (aHBs2)
P
09
0024
Atellica IM Hepatitis B e Antigen (HBeAg)
P
03
0040
Atellica IM Hepatitis B core IgM (aHBcM)
P
03
0040
Atellica IM Hepatitis B core IgM (aHBcM) assay; Atellica IM Hepatitis B core lgM Quality Control (aHBcM QC)
P
08
0023
ARCHITECT CORE, LN 6L22
P
11
0029
ARCHITECT HBsAG Qualitative Reagent Kit (100/500 Test), ARCHITECT HBsAG Qualitative Confirmatory Reagent Kit
P
01
0054
Elecsys Ani-HBs, PreciControl Anti-HBs and Anti-HBs CalCheck
P
09
0024
Atellica IM Hepatitis B e Antigen (HBeAg)
P
04
0004
Atellica IM Anti-Hepatitis B core Total (HBcT), Atellica IM Anti-Hepatitis B core Total Quality Control (HBcT QC)
P
10
0001
VITROS Immunodiagnostic Products Anti-HBe Reagent Pack and Calibrator
P
03
0026
VITROS Immunodiagnostic Products Anti-HBc IgM Reagent Pack and Calibrator
P
00
0014
VITROS Immunodiagnostic Products Anti-HBs Quantitative Reagent Pack and Calibrator
P
03
0024
VITROS Immunodiagnostic Products Anti-HBc Reagent Pack and Calibrator
P
09
0028
VITROS Immunodiagnostic Products HBeAg Reagent Pack and Calibrator
P
00
0044
VITROS Immunodiagnostic Products HBsAg Reagent Pack, Calibrator and Confirmatory Kit
P
09
0028
VITROS Immunodiagnostic Products HBeAg Reagent Pack and Calibrator
P
00
0014
VITROS Immunodiagnostic Products Anti-HBs Quantitative Reagent Pack and Calibrator
P
10
0001
VITROS Immunodiagnostic Products Anti-HBe Reagent Pack and Calibrator
P
00
0044
VITROS Immunodiagnostic Products HBsAg Reagent Pack, Calibrator and Confirmatory Kit
P
03
0026
VITROS Immunodiagnostic Products Anti-HBc IgM Reagent Pack and Calibrator
P
03
0024
VITROS Immunodiagnostic Products Anti-HBc Reagent Pack and Calibrator
P
99
0043
ETI-EBK PLUS Assay
P
99
0038
ETI-MAK-2 PLUS, HBsAg Confirmatory Test Assays
P
99
0042
ETI-AB-AUK PLUS Assay
P
99
0012
Elecsys HBsAg Immunoassay
P
13
0015
Elecsys HBcAg
P
11
0022
Elecsys Anti-HBc IgM
P
10
0031
Elecsys Anti-HBc II
P
16
0019
Elecsys HBsAg II
P
01
0054
Elecsys Anti-HBs
P
11
0041
Advia Centaur HBsll
P
10
0039
Atellica IM Anti-Hepatitis B surface Antigen 2 (aHBs2), Atellica IM Anti-Hepatitis B surface Antigen 2 Quality Control (
P
01
0054
Elecsys Anti-HBs, PreciControl Anti-HBs and Anti-HBs CalCheck
P
03
0040
Atellica IM Hepatitis B core Antigen (aHBcM)
P
99
0038
ETI-MAK-2 PLUS and HBsAg Confirmatory Test Assays
P
99
0042
ETI-AB-AUK PLUS Assay
P
99
0043
ETI-EBK PLUS Assay
P
10
0032
Elecsys Anti-HBc II
P
11
0031
Elecsys Anti-HBc IgM
P
99
0012
Elecsys HBsAg Immunoassay
P
01
0054
Elecsys Anti-HBs Immunoassay
P
10
0031
Elecsys Anti-HBc II
P
11
0041
ADVIA Centaur HBsAgII (HBsII), ADVIA Centaur HBsAg Confirmatory, ADVIA Centaur HBsAg Quality Control
P
99
0043
ETI-EBK PLUS Assay
P
99
0042
ETI-AB-AUK PLUS Assay
P
99
0038
ETI-MAK-2 PLUS and HBsAg Confirmatory Test Assays
P
13
0015
Elecsys HBeAg and PreciControl HBeAg
P
03
0026
VITROS Immunodiagnostic Products Anti-HBc IgM Reagent Pack and Calibrator
P
09
0028
HBeAg Reagent Pack and Calibrator
P
10
0001
Vitros Immunodiagnostic Products Anti-HBe Reagent Pack and Calibrator
P
10
0031
Elecsys Anti-HBc II, PreciControl Anti-HBc
P
16
0019
Elecsys HBsAg II/Elecsys HBsAg Confirmatory Test/ PreciControl HBsAg II
P
16
0019
Elecsys HBsAg II/Elecsys HBsAg Confirmatory Test/ PreciControl HBsAg II
P
11
0022
Elecsys Anti-HBc IgM and PreciControl Anti-HBc IgM
P
10
0031
Elecsys Anti-HBc II
P
11
0031
Elecsys Anti-HBc IgM
P
99
0012
Elecsys HBsAg Immunoassay
P
11
0025
Elecsys Anti-HBc IgM
P
01
0054
Elecsys Anti-HBs
P
16
0019
Elecsys HBsAg II
P
13
0015
Elecsys HBeAg
P
10
0032
Elecsys Anti-HBc II
P
11
0022
Elecsys Anti-HBc IgM
P
00
0044
Vitros Immunodiagnostic Products HBs Ag Reagent Pack and Calibrator
P
16
0019
Elecsys HBsAg II/Elecsys HBsAg Confirmatory Test/ PreciControl HBsAg II
P
09
0028
VITROS Immunodiagnostic Products HBeAg Reagent Pack / VITROS Immunodiagnostic Products HBeAg Calibrator
P
99
0038
ETI MAK-2 PLUS and HBsAg Confirmatory Test assays
P
99
0043
ETI-EBK PLUS assay
P
99
0042
ETI-AB-AUK PLUS assay
P
11
0029
ARCHITECT HBSAG QUALITATIVE, QUALITATIVE CONFIRMATORY, CONFIRMATORY MANUAL DILUENT, CALIBRATORS, AND CONTROLS
P
10
0001
VITROS Immunodiagnostic Products Anti-HBe Reagent Pack and Calibrator
P
09
0028
VITROS IMMUNODIAGNOSTIC PRODUCTS HBEAG REAGENT PACK/PRODUCTS HBEAG CALIBRATOR/PRODUCTS HBE CONTROLS
P
10
0001
VITROS ANTI-HBE REAGENT PACK/ANTI-HBE CALIBRATOR/ANTI HBE CONTROLS
P
03
0024
VITROS Immunodiagnostic Products Anti-HBc Reagent Pack and Calibrator
P
13
0015
Elecsys HBeAg
P
10
0032
Elecsys Anti-HBc
P
11
0031
Elecsys Anit-HBc IgM
P
11
0025
Elecsys Anit-HBc IgM
P
10
0031
Elecsys Anti-HBc
P
01
0054
Elecsys Anit-HBs
P
16
0019
Elecsys HBsAg II
P
11
0022
Elecsys Anit-HBc IgM
P
99
0012
Elecsys HBsAg
P
13
0015
Elecsys HBeAg and PreciControl HBeAg
P
10
0031
Elecsys Anti-HBc Immunoassay test system
P
10
0032
Elecsys Anti-HBC Immunoassay test system
P
00
0044
VITROS Immunodiagnostic Products HBsAg Reagent Pack; VITROS Immunodiagnostic Products HBsAg Calibrator
P
11
0025
Elecsys Anti-HBc IgM Immunoassay
P
11
0022
Elecsys Anti-HBc IgM Immunoassay
P
11
0031
Elecsys Anti-HBc IgM Immunoassay
P
10
0031
Elecsys Anti-HBc Immunoassay
P
16
0019
Elecsys HBsAg II (100/200 tests) Immunoassay
P
01
0054
Elecsys Anti-HBs Immunoassay
P
13
0015
Elecsys HBeAg Immunoassay
P
10
0032
Elecsys Anti-HBc Immunoassay
P
99
0038
DiaSorin ETI-MAK-2 PLUS
P
99
0042
DiaSorin ETI-AB-AUK PLUS assay
P
99
0043
DiaSorin ETI-EBK PLUS assay
P
99
0038
ETI MAK-2 PLUS and HBsAg Confirmatory Test assays
P
99
0043
ETI-EBK PLUS assay
P
99
0042
ETI-AB-AUK PLUS assay
P
09
0024
ADVIA Centaur HBeAg
P
11
0031
Elecsys Anti-HBc IgM, PreciControl Anti-HBc IgM
P
11
0025
Elecsys Anti-HBc IgM, PreciControl Anti-HBc IgM
P
11
0022
Elecsys Anti-HBc IgM, PreciControl Anti-HBc IgM
P
11
0025
MODULAR ANALYSTICS E170
P
11
0031
COBAS E 411
P
11
0022
COBAS E 601
P
13
0015
ELECSYS HBEAG AND PRECICONTROL HBEAG
P
03
0040
ADVIA CENTAUR HBC IGM READYPACK REAGENTS, ADVIA CENTAUR HBC IGM QUALITY CONTROL MATERIALS
P
16
0019
Elecsys HBsAg II/Elecsys HBsAg Confirmatory Test/ PreciControl HBsAg II
P
11
0025
ELECSYS ANTI-HBC IGM IMMUNOASSAY & ELECSYS PREICONTROL ANTI-HBC IGM
P
11
0022
ELECSYS ANTI-HBC IGM IMMUNOASSAY AND ELECSYS PRECICONTROL ANTI-HBC IGM
P
11
0031
ELECSYS ANTI-HBC IGM IMMUNOASSAY AND ELECSYS PRECICONTROL ANTI-HBC IGM
P
05
0051
ABBOTT ARCHITECT AUSAB
P
01
0054
ELECSYS ANTI-HBS
P
13
0015
ELECSYS HBEAG
P
99
0012
ELECSYS HBSAG
P
11
0029
ARCHITECT HBSAG QUALITATIVE, QUALITATIVE CONFIRMATORY,
P
11
0041
ADVIA CENTAUR HBSAGII (HBSII);ADVIA CENTAUR XP HBSAG CONFIRMATORY
P
13
0015
ELECSYS® HBEAG IMMUNOASSAY AND ELECSYS® PRECICONTROL HBEAG
P
09
0024
ADVIA CENTAUR HEPATITIS B E ANTIGEN ASSAY
P
10
0001
VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBE REAGENT PACK/ANTI-HBE CALIBRATOR
P
10
0039
ADVIA CENTAUR ANTI HBS2 ASSAY
P
04
0004
ADVIA CENTAUR HBC TOTAL ASSAY
P
11
0025
ELECSYS ANTI-HBC IGM IMMUNOASSAY
P
11
0031
ELECSYS ANTI-HBC IGM IMMUNOASSAY
P
10
0031
Elecsys Anti-HBc II, PreciControl Anti-HBc
P
01
0054
ELECSYS ANTI-HBS IMMUNOASSAY
P
99
0012
ELECSYS HBSAG IMMUNOASSAY
P
11
0022
ELECSYS ANTI-HBC IGM IMMUNOASSAY
P
13
0015
ELECSYS HBEAG IMMUNOASSAY
P
10
0032
ELECSYS ANTI-HBC IMMUNOASSAY
P
05
0051
ABBOTT ARCHITECT AUSAB
P
99
0042
ETI-AB-AUK PLUS ASSAY
P
99
0043
DIASORIN ETI-EBK PLUS ASSAY
P
99
0038
ETI-MAK-2 PLUS ASSAY AND HBsAg CONFIRMATORY TEST ASSAYS
P
11
0029
ARCHITECT HBSAG QUALITATIVE, QUALITATIVE CONFIRMATORY, CONFIRMATORY MANUAL DILUENT, CALIBRATORS, AND CONTROLS
P
00
0044
VITROS IMMUNODIAGNOSTIC PRODUCTS/HBSAG REAGENT PACK,VITROS IMMUNODIAGNOSTIC PRODUCTS CONFIRMATORY KIT, AND VITROS IMMUNR
P
99
0012
ELECSYS HBSAG IMMUNOASSAY, ELECSYS HBSAG CONFIRMATORY, AND PRECICONTROL HBSAG
P
10
0032
ELECSYS ANTI-HBC IMMUNOASSAY, ELECSYS PRECICONTROL ANTI-HBC FOR USE ON THE ELECSYS 2010 IMMUNOASSAY ANALYZER
P
11
0022
ELECSYS ANTI-HBC IGM IMMUNOASSAY AND ELECSYS PRECICONTROL ANTI-HBC IGM
P
13
0015
ELECSYS® HBEAG IMMUNOASSAY AND ELECSYS® PRECICONTROL HBEAG
P
01
0054
ELECSYS ANTI-HBS
P
11
0031
ELECSYS ANTI-HBC IGM IMMUNOASSAY AND ELECSYS PRECICONTROL ANTI-HBC IGM
P
10
0031
ELECSYS ANTI-HBC IMMUNOASSAY & ELECSYS PRECICONTROL ANTI-HBC
P
11
0025
ELECSYS ANTI-HBC IGM IMMUNOASSAY & ELECSYS PREICONTROL ANTI-HBC IGM FOR USE ON THE MODULAR ANAYTICS E170 IMMUNOASSAY ANA
P
03
0040
ADVIA CENTAUR AHBCM ASSAY
P
01
0054
ELECSYS ANTI-HBS TEST SYSTEM
P
11
0031
ELECSYS ANTI-HBC IGM TEST SYSTEM
P
11
0025
ELECSYS ANTI-HBC IGM TEST SYSTEM
P
11
0022
ELECSYS ANTI-HBC IGM TEST SYSTEM
P
10
0032
ELECSYS ANTI-HBC TEST SYSTEM
P
10
0031
ELECSYS ANTI-HBC TEST SYSTEM
P
99
0012
ELECSYS HBSAG TEST SYSTEM
P
00
0014
VITROS IMMUNADIAGNOSTIC PRODUCTS ANTI-HBS QUANTITATIVE REAGENT PACK, VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBS CALIBRATO
P
13
0015
ELECSYS HBEAG
P
11
0031
ELECSYS ANTI-HBC-IGM
P
11
0025
ELECSYS ANTI-HBC-IGM
P
11
0022
ELECSYS ANTI-HBC-IGM
P
10
0032
ELECSYS ANTI-HBC
P
10
0031
ELECSYS ANTI-HBC
P
01
0054
ELECSYS ANTI-HBS
P
99
0012
ELECSYS HBSAG
P
00
0044
VITROS IMMUNODIAGNOSTIC PRODUCTS HBSAG REGENT PACK, VITROS IMMUNODIAGNOSTIC PRODUCTS HBSAG CALIBRATOR
P
03
0026
VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC IGM REAGENT PACK, VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC IGM CALIBRATOR
P
10
0001
VITROS ANTI-HBE ASSAY
P
03
0026
VITROS ANTI-HBC IGM ASSAY
P
00
0014
VITROS ANTI-HBS ASSAY
P
00
0044
VITROS HBSAG ASSAY
P
03
0024
VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC REAGENT PACK AND CALIBRATOR
P
09
0028
VITROS HBEAG ASSAY
P
11
0029
ARCHITECT HBSAG QUALITATIVE (LN 4P53), ARCHITECT HBSAG QUALITATIVE CONFIRMATORY (LN 4P54)
P
05
0051
ARCHITECT AUSAB (LN 1L82)
P
08
0023
ARCHITECT CORE (LN 6L22)
P
06
0035
ARCHITECT CORE-M (LN 6L23)
P
13
0015
ELECSYS HBEAG IMMUNOASSAY/ELECSYS PRECICONTROL HBEAG
P
01
0052
IMMULITE ANTI-HEPATITIS B SURFACE ANTIGEN (ANTI-HBS) SYSTEMS
P
00
0014
VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBS REAGENT PACK AND CALIBRATOR
P
09
0028
VITROS IMMUNODIAGNOSTIC PRODUCTS HBEAG REAGENT PACK AND CALIBRATOR
P
10
0001
VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBE REAGENT PACK AND CALIBRATOR
P
03
0024
VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC REAGENT PACK AND CALIBRATOR
P
00
0044
VITROS IMMUNODIAGNOSTIC PRODUCTS HBSAG REAGENT PACK AND CALIBRATOR
P
11
0029
ARCHITECT HBSAG QUALITATIVE(LN 4P53), ARCHITECT HBSAG QUALITATIVE CONFIRMATORY (LN 4P54) ASSAYS
P
03
0049
ADVIA CENTAUR HBSAG ASSAY
P
11
0041
ADVIA CENTAUR HBSAGII ASSAY
P
10
0039
ADVIA CENTAUR ANTI-HBS2 (AL-BS2) ASSAY
P
04
0004
ADVIA CENTAUR HBC TOTAL ASSAY
P
09
0024
ADVIA CENTAUR HBEAG ASSAY
P
03
0040
ADVIA CENTAUR HBC IGM ASSAY
P
04
0004
ADVIA CENTAUR HBC TOTAL READYPACK REAGENTS, ADVIA CENTAUR HBC TOTAL QUALITY CONTROL
P
03
0026
VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC IGM REAGENT PACK AND CALIBRATOR
P
11
0041
ADVIA CENTAUR HBSAGII ASSAY
P
05
0051
ARCHITECT AUSAB PMA ASSAY
P
11
0029
ARCHITECT HBSAG QUALITATIVE/CONFIRMATORY PMA ASSAYS
P
01
0054
ELECSYS ANTI-HBS CALCHECK
P
99
0012
ELECSYS HBSAG CONFIRMATORY TEST
P
11
0029
ARCHITECT HBSAG QUALITATIVE AND ARCHITECT HBSAG QUALITATIVE CONFIRMATORY
P
00
0014
VITROS IMMUNODIAGNOSTIC ANTI-HBS QUANTITATIVE REAGENT PACK, VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBS CALIBRATORS
P
11
0029
ARCHITECT HBSAG QUALITATIVE
P
05
0051
ARCHITECT AUSAB
P
08
0023
ARCHITECT CORE
P
06
0035
ARCHITECT CORE-M
P
11
0022
ELECSYS ANTI-HBC IGM ON COBAS E 601
P
10
0031
ELECSYS ANTI-HBC ON COBAS E 601
P
11
0025
ELECSYS ANTI-HBC IGM ON MODULAR ANALYTICS E170
P
13
0015
ELECSYS HBEAG ON MODULAR ANALYTICS E170
P
01
0050
IMMULITE HBSAG, IMMULITE 2000 HBSAG
P
05
0051
ARCHITECT AUSAB (LN 1L82)
P
03
0049
ADVIA CENTAUR HBSAG (HBS) ASSAY
P
08
0023
ARCHITECT CORE (LN 6L22)
P
06
0035
ARCHITECT CORE-M (LN 6L23)
P
99
0045
ETI-AB-COREK PLUS ASSAY
P
99
0042
ETI-AB-AUK-PLUS
P
99
0043
ETI-EBK PLUS ASSAY
P
99
0044
ETI-CORE-IGMK PLUS ASSAY
P
99
0038
ETI-MAK-2 PLUS ASSAY
P
99
0041
ETI-AB-EBK PLUS ASSAY
P
10
0031
ELECSYS ANTI-HBC
P
01
0054
ELECSYS ANTI-HBS
P
99
0012
ELECSYS HBS AG
P
11
0022
ELESYS ANTI-HBC IGM
P
13
0015
ELECSYS HBEAG IMMUNOASSAY AND ELECSYS PRECICONTROL HBEAG
P
11
0041
ADVIA CENTAUR HBSAGII
P
05
0051
ARCHITECT AUSAB
P
11
0029
ARCHITECT HBSAG QUALITATIVE/CONFIRMATORY
P
01
0054
ELECSYS ANTI-HBS IMMUNOASSAY
P
10
0032
ELECSYS ANTI-HBC IMMUNOASSAY
P
99
0012
ELECSYS HBSAG IMMUNOASSAY
P
06
0034
MONOLISA ANTI-HBC IGM EIA
P
13
0015
ELECSYS® HBEAG IMMUNOASSAY AND ELECSYS® PRECICONTROL HBEAG
P
00
0014
ANTI-HBS QUANTITATIVE REAGENT PACK AND CALIBRATORS
P
99
0042
ETI-AB-AUK PLUS ASSAY
P
99
0038
ETI-MAK-2 PLUS ASSAY
P
99
0041
ETI-AB-EBK PLUS ASSAY
P
99
0043
ETI-EBK PLUS
P
99
0044
ETI-CORE-IGMK PLUS
P
99
0045
ETI-AB-COREK PLUS ASSAY
P
05
0051
ARCHITECT AUSAB ASSAY
P
10
0031
ELECSYS ANTI-HBC TEST SYSTEM
P
11
0022
ELECSYS ANTI-HBC IGM TEST SYSTEM
P
10
0032
ELECSYS ANTI-HBC TEST SYSTEM
P
06
0031
BIO-RAD MONOLISA ANTI-HBC EIA
P
05
0048
BIO-RAD MONOLISA ANTI-HBS EIA
P
06
0034
BIO-RAD MONOLISA ANTI-HBC IGM EIA
P
11
0029
ARCHITECT HBSAG QUALITATIVE/CONFIRMATORY
P
08
0023
ARCHITECT CORE
P
11
0029
ARCHITECT HBSAG QUAL/CONF
P
05
0051
ARCHITECT AUSAB
P
06
0035
ARCHITECT CORE-M
P
06
0035
ARCHITECT CORE-M
P
11
0029
ARCHITECT HBSAG QUALITATIVE/CONFIRMATORY
P
05
0051
ARCHITECT AUSAB
P
08
0023
ARCHITECT CORE
P
11
0029
ARCHITECT HBSAG QUALITATIVE CONFIRMATORY , LN 4P54
P
05
0051
ARCHITECT AUSAB LN 1L82
P
10
0001
VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBE REAGENT PACK AND CALIBRATOR
P
09
0028
VITROS IMMUNODIAGNOSTIC PRODUCTS HBEAG REAGENT PACK AND CALIBRATOR
P
03
0026
VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC IGM REAGENT PACK AND CALIBRATOR
P
10
0039
ADVIA CENTAUR ANTI-HBS2 ASSAY
P
08
0023
ARCHITECT CORE
P
10
0039
ADVIA CENTAUR ANTI-HBS2 MASTER CURVE MATERIALS
P
03
0024
VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC REAGENT PACK AND CALIBRATOR
P
10
0031
ELECSYS ANTI-HBC IMMUNOASSAY AND ELECSYS PRECICONTROL ANTI-HBC
P
11
0029
ABBOTT ARCHITECT HBSAG QUALITATIVE CONFIRMATORY REAGENT
P
11
0031
ELECSYS ANTI-HBC IGM ASSAY (COBAS E 411 ANALYZER)
P
11
0022
ELECSYS ANTI-HBC IGM ASSAY (COBAS E 601 ANALYZER)
P
11
0025
ELECSYS ANTI-HBC IGM ASSAY (MODULAR ANALYTICS E170 ANALYZER)
P
06
0007
ARCHITECT HBSAG/HBSAG CONFIRMATORY
P
05
0051
ARCHITECT AUSAB
P
99
0045
ETI-AB-COREK PLUS
P
99
0038
ETI-MAK-2 PLUS ASSAY
P
99
0041
ETI-AB-EBK PLUS ASSAY
P
99
0042
ETI-AB-AUK PLUS ASSAY
P
99
0043
ETI-EBK PLUS ASSAY
P
99
0044
ETI-CORE-IGMK PLUS
P
99
0012
ELECSCYS HBSAG IMMUNOASSAY, ELECSYS PRECICONTROL HBSAG, ELECSYS HBSAG CONFIRMATORY TEST
P
06
0035
ARCHITECT CORE-M
P
08
0023
ARCHITECT CORE
P
06
0007
ARCHITECT HBSAG/CONFIRMATORY
P
08
0023
ARCHITECT CORE
P
05
0051
ARCHITECT AUSAB
P
06
0035
ARCHITECT CORE-M
P
11
0029
ARCHITECT HBSAG QUALITATIVE/CONFIRMATORY
P
11
0029
ARCHITECT I1000 SYSTEM
P
10
0001
VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBE
P
03
0026
VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC IGM
P
09
0028
VITROS IMMUNODIAGNOSTIC PRODUCTS ABEAG
P
01
0054
PRECICONTROL ANTI-HBS
P
99
0012
PRECICONTROL HBSAG
P
10
0031
PRECICONTROL ANTI-HBC (MODULAR ANALYTICS E170)
P
11
0031
PRECICONTROL ANTI-HBC IGM (COBAS E 411)
P
11
0025
PRECICONTROL ANTI-HBC IGM (MODULAR ANALYTICS E170)
P
10
0032
PRECICONTROL ANTI-HBC (ELECSYS) 2010
P
11
0022
PRECICONTROL ANTI-HBC IGM (COBAS E 601)
P
10
0032
ELECSYS ANTI-HBC ON ELECSYS 2010
P
99
0012
ELECSYS HBSAG
P
01
0054
ELECSYS ANTI-HBS
P
11
0031
ELECSYS ANTI-HBC IGM ON COBAS E 411
P
11
0025
ELECSYS ANTI-HBC IGM ON MODULAR ANALYTICS E170
P
11
0022
ELECSYS ANTI-HBC IGM ON COBAS E 601
P
10
0031
ELECSYS ANTI-HBC ON MODULAR ANALYTICS E170
P
06
0007
ARCHITECT HBSAG/CONFIRMATORY
P
08
0023
ARCHITECT CORE
P
05
0051
ARCHITECT AUSAB
P
11
0029
ARCHITECT HBSAG QUALITTATIVE/CONFIRMATORY
P
06
0035
ARCHITECT CORE-M
P
08
0023
ARCHITECT CORE
P
06
0035
ARCHITECT CORE-M
P
06
0007
ARCHITECT HBSAG/CONFIRMATORY
P
11
0029
ARCHITECT HBSAG QUALITATIVE/CONFIRMATORY
P
05
0051
ARCHITECT AUSAB
P
08
0023
ARCHITECT CORE
P
06
0012
AXSYM CORE 2.0
P
06
0009
AXSYM CORE-M 2.0
P
05
0051
ARCHITECT AUSAB
P
06
0007
ARCHITECT HBSAG/HBSAG CONFIRMATORY
P
11
0029
ARCHITECT HBSAG QUALITATIVE/HBSAG QUALITATIVE CONFIRMATORY
P
06
0035
ARCHITECT CORE-M
P
05
0049
AXSYM HBSAG/HBSAG CONFIRMATORY
P
06
0003
AXSYM AUSAB
P
99
0043
ETI-EBK PLUS ASSAY
P
99
0045
ETI-AB-COREK PLUS ASSAY
P
99
0044
ETI-CORE-IGMK PLUS ASSAY
P
99
0042
ETI-AB-AUK PLUS ASSAY
P
99
0041
ETI-AB-EBK PLUS ASSAY
P
99
0038
ETI-MAK-2 PLUS ASSAY
P
05
0051
ARCHITECT AUSAB
P
11
0029
ARCHITECT HBSAG QUALITATIVE/CONFIMATORY
P
06
0007
ARCHITECT HBSAG/CONFIMATORY
P
06
0035
ARCHITECT CORE-M
P
08
0023
ARCHITECT CORE
P
09
0028
VITROS IMMUNODIAGNOSTIC PRODUCTS HBEAG REAGENT PACK CALIBRATOR
P
11
0029
ARCHITECT HBSAG QUALITATIVE/CONFIRMATORY
P
10
0001
VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBE REAGENT PACK, VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBE CALIBRATOR
P
06
0034
BIO-RAD MONOLISA ANTI-HBC IGM EIA
P
05
0048
BIO-RAD MONOLISA ANTI-HBS EIA
P
06
0031
BIO-RAD MONOLISA ANTI-HBC EIA
P
09
0028
VITROS IMMUNODIAGNOSTIC PRODUCTS HBEAG REAGENT PACK AND CALIBRATOR
P
00
0044
VITROS IMMUNODIAGNOSTIC PRODUCTS HBSAG REAGENT PACK AND CALIBRATOR
P
03
0026
VITROS ANTI-HBC IGM
P
00
0014
VITROS ANTI-HBS
P
03
0024
VITROS ANTI-HBC
P
10
0001
VITROS ANTI-HBE
P
05
0048
BIO-RAD MONOLISA ANTI-HBS EIA AND MONOLISA ANTI-HBS CALIBRATOR KIT
P
99
0012
ELECSYS HBSAG IMMUNOASSAY, ELECSYS PRECICONTROL HBSAG AND ELECSYS HBSAG CONFIRMATORY TEST SYSTEM
P
99
0012
ELECSYS HBSAG IMMUNOASSAY, ELECSYS PRECICONTROL HBSAG AND ELECSYS HBSAG CONFIRMATORY TEST SYSTEM
P
10
0001
VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBE REAGENT PACK AND CALIBRATOR
P
09
0028
VITROS IMMUNODIAGNOSTIC PRODUCTS HBEAG REAGENT PACK AND CALIBRATOR
P
06
0007
ABBOTT ARCHITECT HBSAG/ARCHITECT HBSAG CONFIRMATORY
P
11
0029