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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
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
K
22
1693
Elecsys Anti-HCV II (08837031190)
3
Cleared 510(K)
P
19
0011
LIAISON XL MUREX HCV Ab; LIAISON XL MUREX Control HCV Ab
APPR
PMA Approval
P
14
0021
ELECSYS ANTI-HCV II IMMUNOASSAY, ELECSYS PRECICONTROL ANTI-HCV
APPR
PMA Approval
P
08
0027
ORAQUICK HCV RAPID ANTIBODY TEST
APPR
PMA Approval
P
09
0009
ELECSYS ANTI-HCV IMMUNOASSAY & ELECSYS PRECICONTROL ANTI-HCV FOR USE ON MODULAR ANALYTICS E170 IMMUNOSSAY ANALYZER
APPR
PMA Approval
P
09
0007
ELECSYS ANTI-HCV IMMUNOASSAY, ELECSYS PRECICONTROL ANTI-HCV FOR USE ON COBAS E411 IMMUNOSSAY ANALYZER
APPR
PMA Approval
P
09
0008
ELECSYS ANTI-HCV IMMUNOASSAY & ELECSYS PRECICONTROL ANTI-HCV FOR USE ON COBAS E601 IMMUNOSSAY ANALYZER
APPR
PMA Approval
P
05
0042
ARCHITECT ANTI-HCV ASSAY; ARCHITECT ANTI-HCV CALIBRATOR; ARCHITECT ANTI-HCV CONTROL
APPR
PMA Approval
P
03
0056
ADVIA CENTAUR HCV READY PACK REAGENTS, ADVIA CENTAUR HCV QUALITY CONTROL MATERIALS
APPR
PMA Approval
P
97
0027
ABBOTT AXSYM ANTIBODY TO HCV
APWD
PMA Approval
P
05
0042
ARCHITECT Anti-HCV, Alinity i Anti-HCV
3
PMA Approval
P
03
0056
ADVIA CENTAUR HCV ReadyPack Reagents and Quality Control Materials
3
PMA Approval
P
01
0021
VITROS Immunodiagnostic Products Anti-HCV Reagent Pack and Calibrator
3
PMA Approval
P
19
0011
LIAISON XL MUREX HCV Ab
3
PMA Approval
P
03
0056
ADVIA Centaur HCV, and Atellica HCV
3
PMA Approval
P
05
0042
Alinity i Anti-HCV Reagent Kit
3
PMA Approval
P
05
0042
Alinity i Anti-HCV
3
PMA Approval
P
05
0042
ARCHITECT Anti-HCV
3
PMA Approval
P
05
0042
ARCHITECT Anti-HCV and Alinity i Anti-HCV
3
PMA Approval
P
19
0011
LIAISON XL MUREX HCV Ab
3
PMA Approval
P
03
0056
Atellica IM Hepatitis C (aHCV) Assay
3
PMA Approval
P
03
0056
ADVIA Centaur and Atellica IM HCV
3
PMA Approval
P
19
0011
LIAISON XL MUREX HCV Ab; LIAISON XL MUREX Control HCV Ab
3
PMA Approval
P
08
0027
OraQuick HCV Rapid Antibody Test
3
PMA Approval
P
05
0042
Architect Anti-HCV and Alinity i Anti-HCV
3
PMA Approval
P
01
0021
VITROS Immunodiagnostic Products Anti-HCV Reagent Pack and Calibrator
3
PMA Approval
P
05
0042
Alinity i Anti-HCV Reagent Kit, Alinity i Anti-HCV Calibrator, Alinity i Anti-HCV Controls
3
PMA Approval
P
09
0009
Elecsys Anti-HCV Immunoassay
3
PMA Approval
P
09
0007
Elecsys Anti-HCV Immunoassay
3
PMA Approval
P
14
0021
Elecsys Anti-HCV II
3
PMA Approval
P
09
0008
Elecsys Anti-HCV Immunoassay
3
PMA Approval
P
03
0056
Atellica IM Hepatitis C (aHCV) Assay
3
PMA Approval
P
05
0042
ARCHITECT Anti-HCV Reagent Kit
3
PMA Approval
P
01
0021
VITROS Immunodiagnostic Products Anti-HCV Reagent Pack and Calibrator
3
PMA Approval
P
08
0027
OraQuick HCV Rapid Antibody Test
3
PMA Approval
P
05
0042
ARCHITECT Anti-HCV (LN 1L79)
3
PMA Approval
P
05
0042
Architect Anti-HCV Regent Kit (100, 500 Test)
3
PMA Approval
P
14
0021
Elecsys ANti-HCV II (100/200 tests)
3
PMA Approval
P
05
0042
ARCHITECT Anti-HCV
3
PMA Approval
P
03
0056
Atellica IM Analyzer Hepatitis C (aHCV)
3
PMA Approval
P
01
0021
VITROS Immunodiagnostic Products Anti-HCV Reagent Pack and Calibrator
3
PMA Approval
P
01
0021
VITROS Immunodiagnostic Products Anti-HCV Reagent Pack and Calibrator
3
PMA Approval
P
14
0021
Elecsys Anti-HCV II
3
PMA Approval
P
09
0008
Elecsys Anti-HCV Immunoassay
3
PMA Approval
P
03
0056
Atellica IM Hepatitis C (aHCV)
3
PMA Approval
P
14
0021
Elecsys Anti-HCV II
3
PMA Approval
P
09
0007
Elecsys Anbti-HCV Immunoassay
3
PMA Approval
P
08
0027
OraQuick HCV Rapid Antibody Test
3
PMA Approval
P
08
0027
OraQuick HCV Rapid Antibody Test
3
PMA Approval
P
08
0027
OraQuick HCV Rapid Antibody Test
3
PMA Approval
P
09
0009
Elecsys Anti-HCV Immunoassay
3
PMA Approval
P
09
0008
Elecsys Anti-HCV Immunoassay
3
PMA Approval
P
14
0021
Elecsys Anti-HCV II
3
PMA Approval
P
09
0007
Elecsys Anti-HCV Immunoassay
3
PMA Approval
P
14
0021
Elecsys Anti-HCV II, PreciControl Anti-HCV
3
PMA Approval
P
08
0027
OraQuick HCV Rapid Antibody Test
3
PMA Approval
P
08
0027
OraQuick HCV Rapid Antibody Test
3
PMA Approval
P
14
0021
Elecsys Anit-HCV II
3
PMA Approval
P
09
0008
Elecsys Anit-HCV
3
PMA Approval
P
09
0009
Elecsys Anit-HCV
3
PMA Approval
P
09
0007
Elecsys Anit-HCV
3
PMA Approval
P
14
0021
Elecsys Anti-HCV II Test System
3
PMA Approval
P
08
0027
OraQuick HCV Antibody Test
3
PMA Approval
P
14
0021
Elecsys Anti-HCV II (100/200 tests) Immunoassay
3
PMA Approval
P
08
0027
OraQuick HCV Rapid Antibody Test
3
PMA Approval
P
08
0027
ORAQUICK HCV RAPID ANTIBODY TEST
3
PMA Approval
P
08
0027
OraQuick HCV Rapid Antibody Test
3
PMA Approval
P
01
0021
VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HCV REAGENT PACK AND CALIBRATOR
3
PMA Approval
P
08
0027
ORAQUICK HCV RAPID ANTIBODY TEST
3
PMA Approval
P
14
0021
ELECSYS ANTI-HCV II IMMUNOASSAY.
3
PMA Approval
P
03
0056
ADVIA Centaur® HCV assay
3
PMA Approval
P
14
0021
ELECSYS ANTI-HCV II IMMUNOASSAY
3
PMA Approval
P
14
0021
ELECSYS ANTI-HCV II TEST SYSTEM
3
PMA Approval
P
08
0027
ORAQUICK HCV RAPID ANTIBODY TEST
3
PMA Approval
P
14
0021
ELECSYS ANTI-HCV II IMMUNOASSAY
3
PMA Approval
P
05
0042
ARCHITECT ANTI-HCV ASSAY; ARCHITECT ANTI-HCV CALIBRATOR; ARCHITECT ANTI-HCV CONTROL
3
PMA Approval
P
09
0008
ELECSYS ANTI-HCV IMMUNOASSAY & ELECSYS PRECICONTROL ANTI-HCV FOR USE ON COBAS E601 IMMUNOSSAY ANALYZER
3
PMA Approval
P
09
0009
ELECSYS ANTI-HCV IMMUNOASSAY & ELECSYS PRECICONTROL ANTI-HCV FOR USE ON MODULAR ANALYTICS E170 IMMUNOSSAY ANALYZER
3
PMA Approval
P
14
0021
ELECSYS ANTI-HCV II IMMUNOASSAY, ELECSYS PRECICONTROL ANTI-HCV
3
PMA Approval
P
09
0007
ELECSYS ANTI-HCV IMMUNOASSAY, ELECSYS PRECICONTROL ANTI-HCV FOR USE ON COBAS E411 IMMUNOSSAY ANALYZER
3
PMA Approval
P
09
0007
ELECSYS ANTI-HCV TEST SYSTEM
3
PMA Approval
P
14
0021
ELECSYS ANTI-HCV II TEST SYSTEM
3
PMA Approval
P
09
0008
ELECSYS ANTI-HCV TEST SYSTEM
3
PMA Approval
P
09
0009
ELECSYS ANTI-HCV TEST SYSTEM
3
PMA Approval
P
08
0027
ORAQUICK HCV RAPID ANTIBODY TEST
3
PMA Approval
P
98
0046
HOME ACCESS HEPATITIS C CHECK
3
PMA Approval
P
09
0008
ELECSYS ANTI-HCV
3
PMA Approval
P
14
0021
ELECSYS ANTI-HCV II
3
PMA Approval
P
09
0009
ELECSYS ANTI-HCV
3
PMA Approval
P
09
0007
ELECSYS ANTI-HCV
3
PMA Approval
P
08
0027
ORAQUICK HCV RAPID ANTIBODY TEST
3
PMA Approval
P
01
0021
VITROS ANTI-HCV ASSAY
3
PMA Approval
P
05
0042
ARCHITECT ANTI-HCV (LN 1L79)
3
PMA Approval
P
01
0021
VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HCV REAGENT PACK AND CALIBRATOR
3
PMA Approval
P
03
0056
ADVIA CENTAUR HCV ASSAY
3
PMA Approval
P
14
0021
ELECSYS ANTI-HCV II IMMUNOASSAY, ELECSYS PRECICONTROL ANTI-HCV
3
PMA Approval
P
01
0021
VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HCV REAGENT PACK & VITRO IMMUNODIAGNOSTIC PRODUCTS ANTI-HCV CALIBRATOR
3
PMA Approval
P
03
0056
ADVIA CENTAUR HCV READYPACKS
3
PMA Approval
P
08
0027
ORAQUICK HCV RAPID ANTIBODY TEST
3
PMA Approval
P
05
0042
ARCHITECT ANTI-HCV
3
PMA Approval
P
05
0042
ARCHITECT ANTI-HCV (LN IL79)
3
PMA Approval
P
08
0027
ORAQUICK HCV RAPID ANTIBODY TEST
3
PMA Approval
P
09
0008
ELECSYS ANTI-HCV IMMUNOASSAY ON COBAS E 601 AND COBAS E 602
3
PMA Approval
P
09
0007
ELECSYS ANTI-HCV IMMUNOASSAY ON COBAS E 411
3
PMA Approval
P
09
0009
ELECSYS ANTI-HCV IMMUNOASSAY ON MODULAR ANALYTICS E 170
3
PMA Approval
P
08
0027
ORAQUICK HCV RAPID ANTIBODY TEST
3
PMA Approval
P
08
0027
ORAQUICK HCV RAPID ANTIBODY TEST
3
PMA Approval
P
09
0008
ELECSYS ANTI-HCV
3
PMA Approval
P
05
0042
ARCHITECT ANTI-HCV
3
PMA Approval
P
08
0027
ORAQUICK HCV RAPID ANTIBODY TEST
3
PMA Approval
P
05
0042
ARCHITECT ANTI-HCV
3
PMA Approval
P
05
0042
ARCHITECT ANTI-HCV
3
PMA Approval
P
05
0042
ARCHITECT ANTI-HCV ASSAY, LN IL79
3
PMA Approval
P
08
0027
ORAQUICK HCV RAPID ANTIBODY TEST
3
PMA Approval
P
08
0027
ORAQUICK HCV RAPID ANTIBODY TEST
3
PMA Approval
P
05
0042
ARCHITECT ANTI-HCV LN 1L79
3
PMA Approval
P
08
0027
ORAQUICK HCV RAPID ANTIBODY TEST
3
PMA Approval
P
08
0027
ORAQUICK HCV RAPID ANTIBODY TEST
3
PMA Approval
P
05
0042
ARCHITECT ANTI-HCV
3
PMA Approval
P
08
0027
ORAQUICK HCV RAPID ANTIBODY TEST
3
PMA Approval
P
08
0027
ORAQUICK HCV RAPID ANTIBODY TEST
3
PMA Approval
P
05
0042
ARCHITECT ANTI-HCV
3
PMA Approval
P
05
0042
ARCHITECT ANTI-HCV
3
PMA Approval
P
01
0021
VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HCV REAGENT PACK
3
PMA Approval
P
08
0027
ORAQUICK HCV RAPID ANTIBODY TEST
3
PMA Approval
P
09
0009
ELECSYS ANTI-HCV IMMUNOASSAY (MODULAR ANALYTICS E170) AND PRECICONTROL ANTI-HCV
3
PMA Approval
P
09
0008
ELECSYS ANTI-HCV IMMUNOASSAY (COBAS E 601) AND PRECICONTROL ANTI-HCV
3
PMA Approval
P
09
0007
ELECSYS ANTI-HCV IMMUNOASSAY (COBAS E 411) AND PRECICONTROL ANTI-HCV
3
PMA Approval
P
09
0007
ELECSYS ANTI-HCV ON COBAS E 411
3
PMA Approval
P
09
0008
ELECSYS ANTI-HCV ON COBAS E 601
3
PMA Approval
P
09
0009
ELECSYS ANTI-HCV ON MODULAR ANALYTICS E170
3
PMA Approval
P
08
0027
ORAQUICK HCV RAPID ANTIBODY TEST
3
PMA Approval
P
05
0042
ARCHITECT ANTI-HCV
3
PMA Approval
P
05
0042
ARCHITECT ANTI-HCV
3
PMA Approval
P
05
0042
ARCHITECT ANTI-HCV
3
PMA Approval
P
97
0027
AXSYM ANTI-HCV
3
PMA Approval
P
01
0021
VITROS ANTI-HCV
3
PMA Approval
P
03
0056
ADVIA CENTAUR HCV ASSAY
3
PMA Approval
P
09
0007
ELECSYS ANTI-HCV IMMUNOASSAY ON CABAS E 411
3
PMA Approval
P
09
0008
ELECSYS ANTI-HCV IMMUNOASSAY ON COBAS E 601
3
PMA Approval
P
09
0009
ELECSYS ANTI-HCV IMMUNOASSAY ON MODULAR ANALYTICS E170
3
PMA Approval
P
05
0042
ARCHITECT ANTI-HCV
3
PMA Approval
P
05
0042
ARCHITECT ANTI-HCV
3
PMA Approval
P
09
0008
ELECSYS ANTI-HCV IMMUNOASSAY
3
PMA Approval
P
05
0042
ARCHTECT ANTI-HCV
3
PMA Approval
P
09
0007
ELECSYS ANTI-HCV ON COBAS E 411
3
PMA Approval
P
09
0009
ELECSYS ANTI-HCV ON MODULAR ANALYTICS E170
3
PMA Approval
P
09
0008
ELECSYS ANTI-HCV ON COBAS E 601
3
PMA Approval
P
01
0021
VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HCV REAGENT PACK AND CALIBRATOR
3
PMA Approval
P
97
0027
AXSYM ANTI-HCV (LN 5C36)
3
PMA Approval
P
05
0042
ACHITECT ANTI-HCV
3
PMA Approval
P
09
0008
ELECSYS ANTI-HCV IMMUNOASSAY COBAS E 601
3
PMA Approval
P
09
0007
ELECSYS ANTI-HCV INMMUNOASSAY ON COBAS E 411
3
PMA Approval
P
09
0009
ELECSYS ANTI-HCV IMMUNOASSAY ON MUDULAR ANALYTICS
3
PMA Approval
P
05
0042
ARCHITECT ANTI-HCV
3
PMA Approval
P
09
0007
ELECSYS ANTI-HCV IMMUNOASSAY ON COBAS E 411
3
PMA Approval
P
09
0009
ELECSYS ANTI-HCV IMMUNOASSAY ON MODULAR ANALYTICS E170
3
PMA Approval
P
09
0008
ELECSYS ANTI-HCV IMMUNOASSAY ON COBAS E 601
3
PMA Approval
P
09
0007
ELECSYS ANTI-HCV IMMUNOASSAY ON COBAS E 411
3
PMA Approval
P
09
0009
ELECSYS ANTI-HCV IMMUNOASSAY ON MODULAR ANALYSTICS E170
3
PMA Approval
P
09
0008
ELECSYS ANTI -HCV IMMUNOASSAY ON COBAS E 601
3
PMA Approval
P
01
0021
VITROS INMMUNODIAGNOSTIC PRODUCTS ANTI-HCV ASSAY
3
PMA Approval
P
08
0027
ORAQUICK RAPID HCV ANTIBODY
3
PMA Approval
P
97
0027
AXSYM ANTI-HCV
3
PMA Approval
P
97
0027
AXSYM ANTI-HCV
3
PMA Approval
P
09
0008
ELECSYS ANTI-HCV IMMUNOASSAY & ELECSYS PRECICONTROL ANTI-HCV FOR USE ON COBAS E601
3
PMA Approval
P
09
0009
ELECSYS ANTI-HCV IMMUNOASSAY & ELECSYS PRECICONTROL ANTI-HCV FOR USE ON E170 IMMUNOASSAY ANALYZER
3
PMA Approval
P
09
0007
ELECSYS ANTI-HCV IMMUNOASSAY & ELECSYS PRECICONTROL ANTI-HCV FOR USE ON COBAS E411
3
PMA Approval
P
01
0021
VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HCV REAGENT PACK AND CALIBRATOR
3
PMA Approval
P
98
0046
HOME ACCESS HEPATITIS C CHECK TEST SYSTEM
3
PMA Approval
P
01
0021
VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HCV REAGENT PACK & CALIBRATOR
3
PMA Approval
P
08
0027
ORAQUICK HCV RAPID ANTIBODY TEST
3
PMA Approval
P
05
0042
ARCHITECT ANTI-HCV
3
PMA Approval
P
05
0042
ARCHITECT ANTI-HCV
3
PMA Approval
P
97
0027
AXSYM ANTI-HCV
3
PMA Approval
P
05
0042
ARCHITECT ANTI-HCV
3
PMA Approval
P
97
0027
AXSYM ANTI-HCV
3
PMA Approval
P
05
0042
ARCHITECT ANTI-HCV
3
PMA Approval
P
09
0008
ELECSYS ANTI-HCV IMMUNOASSAY
3
PMA Approval
P
09
0009
ELECSYS ANTI-HCV IMMUNOASSAY
3
PMA Approval
P
09
0007
ELECSYS ANTI-HCV IMMUNOASSAY
3
PMA Approval
P
08
0027
ORAQUICK HCV RAPID ANTIBODY TEST
3
PMA Approval
P
97
0027
AXSYM ANTI-HCV
3
PMA Approval
P
05
0042
ARCHITECT ANTI-HCV
3
PMA Approval
P
08
0027
ORAQUICK HCV RAPID ANTIBODY TEST
3
PMA Approval
P
05
0042
ARCHITECT ANTI-HCV
3
PMA Approval
P
05
0042
ARCHITECT ANTI-HCV
3
PMA Approval
P
97
0027
AXSYM ANTI-HCV
3
PMA Approval
P
05
0042
ABBOTT ARCHITECT ANTI-HCV
3
PMA Approval
P
97
0027
AXSYM ANTI-HCV (LN 5C36)
3
PMA Approval
P
09
0007
ELECSYS ANTI-HCV IMMUNOASSAY & ELECSYS PRECICONTROL ANTI-HCV FOR USE ON THE ROCHE COBAS E 411 IMMUNOASSAY ANALYZER
3
PMA Approval
P
09
0009
ELECSYS ANTI-HCV IMMUNOASSAY & ELECSYS PRECICONTROL ANTI-HCV FOR USE ON THE MODULAR ANALYTICS E170 IMMUNOASSAY ANALYZER
3
PMA Approval
P
09
0008
ELECSYS ANTI-HCV IMMUNOASSAY & ELECSYS PRECICONTROL ANTI-HCV FOR USE ON THE ROCHE COBAS E 601 IMMUNOASSAY ANALYZER
3
PMA Approval
P
97
0027
AXSYM ANTI-HCV
3
PMA Approval
P
01
0021
ANTI-HCV REAGENT PACK AND CALIBRATOR
3
PMA Approval
P
08
0027
ORAQUICK HCV RAPID ANTIBODY TEST
3
PMA Approval
P
01
0021
VITROS IMMUNODIAGNOSTIC PRODUCT ANTI-HCV REAGENT PACK & CALIBRATOR
3
PMA Approval
P
97
0027
ABBOTT AXSYM ANTI-HCV
3
PMA Approval
P
09
0009
ELECSYS ANTI-HCV IMMUNOASSAY & ELECSYS PRECICONTROL ANTI-HCV FOR USE ON MODULAR ANALYTICS E170 IMMUNOSSAY ANALYZER
3
PMA Approval
P
09
0008
ELECSYS ANTI-HCV IMMUNOASSAY & ELECSYS PRECICONTROL ANTI-HCV FOR USE ON COBAS E601 IMMUNOSSAY ANALYZER
3
PMA Approval
P
09
0007
ELECSYS ANTI-HCV IMMUNOASSAY, ELECSYS PRECICONTROL ANTI-HCV FOR USE ON COBAS E411 IMMUNOSSAY ANALYZER
3
PMA Approval
P
03
0056
ADVIA CENTAUR SOFTWARE V4.0 SP1 ANTI-HCV
3
PMA Approval
P
03
0056
ADVIA CENTAUR XP SOFTWARE V6.0 ANTI-HCV
3
PMA Approval
P
03
0056
ADVIA CENTAUR HCV ON CENTAUR CP
3
PMA Approval
P
01
0021
VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HCV REAGENT PACK AND CALIBRATOR
3
PMA Approval
P
97
0027
ABBOTT AXSYM ANTIBODY TO HCV (ANTI-HCV)
3
PMA Approval
P
05
0042
ARCHITECT ANTI-HCV ASSAY/CALIBRATOR/CONTROL
3
PMA Approval
P
03
0056
ADVIA CENTAUR HCV READYPACK REAGENNTS/QUALITY CONTROL MATERIALS
3
PMA Approval
P
01
0021
VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HCV REAGENT PACK & CALIBRATORS
3
PMA Approval
P
03
0056
ADVIA CENTAUR HCV
3
PMA Approval
P
05
0042
ABBOTT ARCHITECT ANTI-HCV
3
PMA Approval
P
01
0021
VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HCV REAGENT PACK & CALIBRATOR
3
PMA Approval
P
01
0021
VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HCV REAGENT PACK AND CALIBRATOR
3
PMA Approval
P
97
0027
ABBOTT AXSYM ANTI-HCV
3
PMA Approval
P
01
0021
VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HCV REAGENT PACK & CALIBRATORS
3
PMA Approval
P
05
0042
ABBOTT ARCHITECT ANTI-HCV
3
PMA Approval
P
01
0021
VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HCV REAGENT PACK AND VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HCV CALIBRATOR
3
PMA Approval
P
01
0021
VITROS IMMUNODIAGNOSTIC PRODUCTS HCV REAGENT PACK & CALIBRATOR
3
PMA Approval
P
05
0042
ARCHITECT ANTI-HCV
3
PMA Approval
P
97
0027
AXSYM ANTIBODY TO HCV
3
PMA Approval
P
05
0042
ARCHITECT ANTI-HCV REAGENT KITS, ARCHITECT ANTI-HCV CALIBRATORS, AND ARCHITECT ANTI-HCV CONTROLS
3
PMA Approval
P
05
0042
ARCHITECT ANTI-HCV ASSAY; ARCHITECT ANTI-HCV CALIBRATOR; ARCHITECT ANTI-HCV CONTROL
3
PMA Approval
P
01
0021
VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HCV REAGENT PACK AND CALIBRATOR
3
PMA Approval
P
01
0021
VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HCV REAGENT PACK AND CALIBRATOR
3
PMA Approval
P
01
0021
VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HCV REAGENT PACK AND CALIBRATOR
3
PMA Approval
P
01
0021
VITROS IMMUNODIAGNOSTIC ANTI-HCV REAGENT PACK AND CALIBRATOR
3
PMA Approval
P
97
0027
ABBOTT AXSYM ANTI-HCV (LIST NUMBER 5C36)
3
PMA Approval
P
03
0056
ADVIA CENTAUR HCV READY PACK REAGENTS, ADVIA CENTAUR HCV QUALITY CONTROL MATERIALS
3
PMA Approval
P
97
0027
ABBOTT AXSYM ANTI-HCV
3
PMA Approval
P
98
0046
HEPATITS C CHECK TEST SYSTEM
3
PMA Approval
P
97
0027
AXSYM ANTI-HCV
3
PMA Approval
P
01
0021
VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HCV REAGENT PACK & CALIBRATOR
3
PMA Approval
P
01
0021
VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HCV REAGENT PACK AND CALIBRATOR
3
PMA Approval
P
01
0021
VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HCV REAGENT PACK AND CALIBRATORS
3
PMA Approval
P
97
0027
ABBOTT AXSYM ANTI-HCV
3
PMA Approval
P
97
0027
ABBOTT AXSYM ANTIBODY TO HCV
3
PMA Approval
P
98
0046
HOME ACCESS HEPATITIS C CHECK TEST SERVICE
3
PMA Approval
P
01
0021
VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HCV REAGENT PACK & CALIBRATORS
3
PMA Approval
P
98
0046
HOME ACCESS HEPATITIS C TEST SERVICE
3
PMA Approval
P
01
0021
VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HCV REAGENT PACK AND CALIBRATOR
3
PMA Approval
P
98
0046
HOME ACCESS HEPATITIS C CHECK TEST
3
PMA Approval
P
98
0046
HEPATITIS C CHECK TESTING SERVICE
3
PMA Approval
P
98
0046
HOME ACCESS HEPATITIS C CHECK AND HEPATITIS C CHECK EXPRESS
3
PMA Approval
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
Submissions with No Product Code
Miscellaneous
Subpart B—Biological Stains
CFR Sub-Part
Subpart B—Clinical Chemistry Test Systems
CFR Sub-Part
Subpart B—Diagnostic Devices
CFR Sub-Part
Subpart C—Clinical Laboratory Instruments
CFR Sub-Part
Subpart C—Microbiology Devices
CFR Sub-Part
Subpart D—Serological Reagents
CFR Sub-Part
Subpart F—Immunological Test Systems
CFR Sub-Part
Neurology
Review Panel
Obstetrical and Gynecological
Review Panel
Ophthalmic
Review Panel
Orthopedic
Review Panel
Pathology
Review Panel
Physical Medicine
Review Panel
Radiology
Review Panel
General and Plastic Surgery
Review Panel
Toxicology
Review Panel
Medical Genetics
Review Panel
Unknown
Review Panel
Last synced on 30 November 2024 at 11:09 am
MI
/
MI-misc
/
MZO
/
P980046
View Source
HOME ACCESS HEPATITIS C CHECK
Page Type
PMA Approval
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
Applicant
PWNHealth Chicago LLC
Trade Name
HOME ACCESS HEPATITIS C CHECK AND HEPATITIS C CHECK EXPRESS
Generic Name
Assay, enzyme linked immunosorbent, hepatitis c virus
Decision Date
4/28/1999
Days to Decision
142 days
Decision Code
APPR
FDA Decision
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)
LQI
Hepatitis Delta Serological Reagents
MAQ
Kit, Dna Detection, Human Papillomavirus
MHR
Test, Anti-Tumor Cell Susceptibility
MKT
Hepatitis Viral B Dna Detection
MYL
Assay,Enzyme Linked Immunosorbent,Parvovirus B19 Igg
MYM
Assay,Enzyme Linked Immunosorbent,Parvovirus B19 Igm
MZO
Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus
K
22
1693
Elecsys Anti-HCV II (08837031190)
P
19
0011
LIAISON XL MUREX HCV Ab; LIAISON XL MUREX Control HCV Ab
P
14
0021
ELECSYS ANTI-HCV II IMMUNOASSAY, ELECSYS PRECICONTROL ANTI-HCV
P
08
0027
ORAQUICK HCV RAPID ANTIBODY TEST
P
09
0009
ELECSYS ANTI-HCV IMMUNOASSAY & ELECSYS PRECICONTROL ANTI-HCV FOR USE ON MODULAR ANALYTICS E170 IMMUNOSSAY ANALYZER
P
09
0007
ELECSYS ANTI-HCV IMMUNOASSAY, ELECSYS PRECICONTROL ANTI-HCV FOR USE ON COBAS E411 IMMUNOSSAY ANALYZER
P
09
0008
ELECSYS ANTI-HCV IMMUNOASSAY & ELECSYS PRECICONTROL ANTI-HCV FOR USE ON COBAS E601 IMMUNOSSAY ANALYZER
P
05
0042
ARCHITECT ANTI-HCV ASSAY; ARCHITECT ANTI-HCV CALIBRATOR; ARCHITECT ANTI-HCV CONTROL
P
03
0056
ADVIA CENTAUR HCV READY PACK REAGENTS, ADVIA CENTAUR HCV QUALITY CONTROL MATERIALS
P
97
0027
ABBOTT AXSYM ANTIBODY TO HCV
P
05
0042
ARCHITECT Anti-HCV, Alinity i Anti-HCV
P
03
0056
ADVIA CENTAUR HCV ReadyPack Reagents and Quality Control Materials
P
01
0021
VITROS Immunodiagnostic Products Anti-HCV Reagent Pack and Calibrator
P
19
0011
LIAISON XL MUREX HCV Ab
P
03
0056
ADVIA Centaur HCV, and Atellica HCV
P
05
0042
Alinity i Anti-HCV Reagent Kit
P
05
0042
Alinity i Anti-HCV
P
05
0042
ARCHITECT Anti-HCV
P
05
0042
ARCHITECT Anti-HCV and Alinity i Anti-HCV
P
19
0011
LIAISON XL MUREX HCV Ab
P
03
0056
Atellica IM Hepatitis C (aHCV) Assay
P
03
0056
ADVIA Centaur and Atellica IM HCV
P
19
0011
LIAISON XL MUREX HCV Ab; LIAISON XL MUREX Control HCV Ab
P
08
0027
OraQuick HCV Rapid Antibody Test
P
05
0042
Architect Anti-HCV and Alinity i Anti-HCV
P
01
0021
VITROS Immunodiagnostic Products Anti-HCV Reagent Pack and Calibrator
P
05
0042
Alinity i Anti-HCV Reagent Kit, Alinity i Anti-HCV Calibrator, Alinity i Anti-HCV Controls
P
09
0009
Elecsys Anti-HCV Immunoassay
P
09
0007
Elecsys Anti-HCV Immunoassay
P
14
0021
Elecsys Anti-HCV II
P
09
0008
Elecsys Anti-HCV Immunoassay
P
03
0056
Atellica IM Hepatitis C (aHCV) Assay
P
05
0042
ARCHITECT Anti-HCV Reagent Kit
P
01
0021
VITROS Immunodiagnostic Products Anti-HCV Reagent Pack and Calibrator
P
08
0027
OraQuick HCV Rapid Antibody Test
P
05
0042
ARCHITECT Anti-HCV (LN 1L79)
P
05
0042
Architect Anti-HCV Regent Kit (100, 500 Test)
P
14
0021
Elecsys ANti-HCV II (100/200 tests)
P
05
0042
ARCHITECT Anti-HCV
P
03
0056
Atellica IM Analyzer Hepatitis C (aHCV)
P
01
0021
VITROS Immunodiagnostic Products Anti-HCV Reagent Pack and Calibrator
P
01
0021
VITROS Immunodiagnostic Products Anti-HCV Reagent Pack and Calibrator
P
14
0021
Elecsys Anti-HCV II
P
09
0008
Elecsys Anti-HCV Immunoassay
P
03
0056
Atellica IM Hepatitis C (aHCV)
P
14
0021
Elecsys Anti-HCV II
P
09
0007
Elecsys Anbti-HCV Immunoassay
P
08
0027
OraQuick HCV Rapid Antibody Test
P
08
0027
OraQuick HCV Rapid Antibody Test
P
08
0027
OraQuick HCV Rapid Antibody Test
P
09
0009
Elecsys Anti-HCV Immunoassay
P
09
0008
Elecsys Anti-HCV Immunoassay
P
14
0021
Elecsys Anti-HCV II
P
09
0007
Elecsys Anti-HCV Immunoassay
P
14
0021
Elecsys Anti-HCV II, PreciControl Anti-HCV
P
08
0027
OraQuick HCV Rapid Antibody Test
P
08
0027
OraQuick HCV Rapid Antibody Test
P
14
0021
Elecsys Anit-HCV II
P
09
0008
Elecsys Anit-HCV
P
09
0009
Elecsys Anit-HCV
P
09
0007
Elecsys Anit-HCV
P
14
0021
Elecsys Anti-HCV II Test System
P
08
0027
OraQuick HCV Antibody Test
P
14
0021
Elecsys Anti-HCV II (100/200 tests) Immunoassay
P
08
0027
OraQuick HCV Rapid Antibody Test
P
08
0027
ORAQUICK HCV RAPID ANTIBODY TEST
P
08
0027
OraQuick HCV Rapid Antibody Test
P
01
0021
VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HCV REAGENT PACK AND CALIBRATOR
P
08
0027
ORAQUICK HCV RAPID ANTIBODY TEST
P
14
0021
ELECSYS ANTI-HCV II IMMUNOASSAY.
P
03
0056
ADVIA Centaur® HCV assay
P
14
0021
ELECSYS ANTI-HCV II IMMUNOASSAY
P
14
0021
ELECSYS ANTI-HCV II TEST SYSTEM
P
08
0027
ORAQUICK HCV RAPID ANTIBODY TEST
P
14
0021
ELECSYS ANTI-HCV II IMMUNOASSAY
P
05
0042
ARCHITECT ANTI-HCV ASSAY; ARCHITECT ANTI-HCV CALIBRATOR; ARCHITECT ANTI-HCV CONTROL
P
09
0008
ELECSYS ANTI-HCV IMMUNOASSAY & ELECSYS PRECICONTROL ANTI-HCV FOR USE ON COBAS E601 IMMUNOSSAY ANALYZER
P
09
0009
ELECSYS ANTI-HCV IMMUNOASSAY & ELECSYS PRECICONTROL ANTI-HCV FOR USE ON MODULAR ANALYTICS E170 IMMUNOSSAY ANALYZER
P
14
0021
ELECSYS ANTI-HCV II IMMUNOASSAY, ELECSYS PRECICONTROL ANTI-HCV
P
09
0007
ELECSYS ANTI-HCV IMMUNOASSAY, ELECSYS PRECICONTROL ANTI-HCV FOR USE ON COBAS E411 IMMUNOSSAY ANALYZER
P
09
0007
ELECSYS ANTI-HCV TEST SYSTEM
P
14
0021
ELECSYS ANTI-HCV II TEST SYSTEM
P
09
0008
ELECSYS ANTI-HCV TEST SYSTEM
P
09
0009
ELECSYS ANTI-HCV TEST SYSTEM
P
08
0027
ORAQUICK HCV RAPID ANTIBODY TEST
P
98
0046
HOME ACCESS HEPATITIS C CHECK
P
09
0008
ELECSYS ANTI-HCV
P
14
0021
ELECSYS ANTI-HCV II
P
09
0009
ELECSYS ANTI-HCV
P
09
0007
ELECSYS ANTI-HCV
P
08
0027
ORAQUICK HCV RAPID ANTIBODY TEST
P
01
0021
VITROS ANTI-HCV ASSAY
P
05
0042
ARCHITECT ANTI-HCV (LN 1L79)
P
01
0021
VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HCV REAGENT PACK AND CALIBRATOR
P
03
0056
ADVIA CENTAUR HCV ASSAY
P
14
0021
ELECSYS ANTI-HCV II IMMUNOASSAY, ELECSYS PRECICONTROL ANTI-HCV
P
01
0021
VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HCV REAGENT PACK & VITRO IMMUNODIAGNOSTIC PRODUCTS ANTI-HCV CALIBRATOR
P
03
0056
ADVIA CENTAUR HCV READYPACKS
P
08
0027
ORAQUICK HCV RAPID ANTIBODY TEST
P
05
0042
ARCHITECT ANTI-HCV
P
05
0042
ARCHITECT ANTI-HCV (LN IL79)
P
08
0027
ORAQUICK HCV RAPID ANTIBODY TEST
P
09
0008
ELECSYS ANTI-HCV IMMUNOASSAY ON COBAS E 601 AND COBAS E 602
P
09
0007
ELECSYS ANTI-HCV IMMUNOASSAY ON COBAS E 411
P
09
0009
ELECSYS ANTI-HCV IMMUNOASSAY ON MODULAR ANALYTICS E 170
P
08
0027
ORAQUICK HCV RAPID ANTIBODY TEST
P
08
0027
ORAQUICK HCV RAPID ANTIBODY TEST
P
09
0008
ELECSYS ANTI-HCV
P
05
0042
ARCHITECT ANTI-HCV
P
08
0027
ORAQUICK HCV RAPID ANTIBODY TEST
P
05
0042
ARCHITECT ANTI-HCV
P
05
0042
ARCHITECT ANTI-HCV
P
05
0042
ARCHITECT ANTI-HCV ASSAY, LN IL79
P
08
0027
ORAQUICK HCV RAPID ANTIBODY TEST
P
08
0027
ORAQUICK HCV RAPID ANTIBODY TEST
P
05
0042
ARCHITECT ANTI-HCV LN 1L79
P
08
0027
ORAQUICK HCV RAPID ANTIBODY TEST
P
08
0027
ORAQUICK HCV RAPID ANTIBODY TEST
P
05
0042
ARCHITECT ANTI-HCV
P
08
0027
ORAQUICK HCV RAPID ANTIBODY TEST
P
08
0027
ORAQUICK HCV RAPID ANTIBODY TEST
P
05
0042
ARCHITECT ANTI-HCV
P
05
0042
ARCHITECT ANTI-HCV
P
01
0021
VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HCV REAGENT PACK
P
08
0027
ORAQUICK HCV RAPID ANTIBODY TEST
P
09
0009
ELECSYS ANTI-HCV IMMUNOASSAY (MODULAR ANALYTICS E170) AND PRECICONTROL ANTI-HCV
P
09
0008
ELECSYS ANTI-HCV IMMUNOASSAY (COBAS E 601) AND PRECICONTROL ANTI-HCV
P
09
0007
ELECSYS ANTI-HCV IMMUNOASSAY (COBAS E 411) AND PRECICONTROL ANTI-HCV
P
09
0007
ELECSYS ANTI-HCV ON COBAS E 411
P
09
0008
ELECSYS ANTI-HCV ON COBAS E 601
P
09
0009
ELECSYS ANTI-HCV ON MODULAR ANALYTICS E170
P
08
0027
ORAQUICK HCV RAPID ANTIBODY TEST
P
05
0042
ARCHITECT ANTI-HCV
P
05
0042
ARCHITECT ANTI-HCV
P
05
0042
ARCHITECT ANTI-HCV
P
97
0027
AXSYM ANTI-HCV
P
01
0021
VITROS ANTI-HCV
P
03
0056
ADVIA CENTAUR HCV ASSAY
P
09
0007
ELECSYS ANTI-HCV IMMUNOASSAY ON CABAS E 411
P
09
0008
ELECSYS ANTI-HCV IMMUNOASSAY ON COBAS E 601
P
09
0009
ELECSYS ANTI-HCV IMMUNOASSAY ON MODULAR ANALYTICS E170
P
05
0042
ARCHITECT ANTI-HCV
P
05
0042
ARCHITECT ANTI-HCV
P
09
0008
ELECSYS ANTI-HCV IMMUNOASSAY
P
05
0042
ARCHTECT ANTI-HCV
P
09
0007
ELECSYS ANTI-HCV ON COBAS E 411
P
09
0009
ELECSYS ANTI-HCV ON MODULAR ANALYTICS E170
P
09
0008
ELECSYS ANTI-HCV ON COBAS E 601
P
01
0021
VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HCV REAGENT PACK AND CALIBRATOR
P
97
0027
AXSYM ANTI-HCV (LN 5C36)
P
05
0042
ACHITECT ANTI-HCV
P
09
0008
ELECSYS ANTI-HCV IMMUNOASSAY COBAS E 601
P
09
0007
ELECSYS ANTI-HCV INMMUNOASSAY ON COBAS E 411
P
09
0009
ELECSYS ANTI-HCV IMMUNOASSAY ON MUDULAR ANALYTICS
P
05
0042
ARCHITECT ANTI-HCV
P
09
0007
ELECSYS ANTI-HCV IMMUNOASSAY ON COBAS E 411
P
09
0009
ELECSYS ANTI-HCV IMMUNOASSAY ON MODULAR ANALYTICS E170
P
09
0008
ELECSYS ANTI-HCV IMMUNOASSAY ON COBAS E 601
P
09
0007
ELECSYS ANTI-HCV IMMUNOASSAY ON COBAS E 411
P
09
0009
ELECSYS ANTI-HCV IMMUNOASSAY ON MODULAR ANALYSTICS E170
P
09
0008
ELECSYS ANTI -HCV IMMUNOASSAY ON COBAS E 601
P
01
0021
VITROS INMMUNODIAGNOSTIC PRODUCTS ANTI-HCV ASSAY
P
08
0027
ORAQUICK RAPID HCV ANTIBODY
P
97
0027
AXSYM ANTI-HCV
P
97
0027
AXSYM ANTI-HCV
P
09
0008
ELECSYS ANTI-HCV IMMUNOASSAY & ELECSYS PRECICONTROL ANTI-HCV FOR USE ON COBAS E601
P
09
0009
ELECSYS ANTI-HCV IMMUNOASSAY & ELECSYS PRECICONTROL ANTI-HCV FOR USE ON E170 IMMUNOASSAY ANALYZER
P
09
0007
ELECSYS ANTI-HCV IMMUNOASSAY & ELECSYS PRECICONTROL ANTI-HCV FOR USE ON COBAS E411
P
01
0021
VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HCV REAGENT PACK AND CALIBRATOR
P
98
0046
HOME ACCESS HEPATITIS C CHECK TEST SYSTEM
P
01
0021
VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HCV REAGENT PACK & CALIBRATOR
P
08
0027
ORAQUICK HCV RAPID ANTIBODY TEST
P
05
0042
ARCHITECT ANTI-HCV
P
05
0042
ARCHITECT ANTI-HCV
P
97
0027
AXSYM ANTI-HCV
P
05
0042
ARCHITECT ANTI-HCV
P
97
0027
AXSYM ANTI-HCV
P
05
0042
ARCHITECT ANTI-HCV
P
09
0008
ELECSYS ANTI-HCV IMMUNOASSAY
P
09
0009
ELECSYS ANTI-HCV IMMUNOASSAY
P
09
0007
ELECSYS ANTI-HCV IMMUNOASSAY
P
08
0027
ORAQUICK HCV RAPID ANTIBODY TEST
P
97
0027
AXSYM ANTI-HCV
P
05
0042
ARCHITECT ANTI-HCV
P
08
0027
ORAQUICK HCV RAPID ANTIBODY TEST
P
05
0042
ARCHITECT ANTI-HCV
P
05
0042
ARCHITECT ANTI-HCV
P
97
0027
AXSYM ANTI-HCV
P
05
0042
ABBOTT ARCHITECT ANTI-HCV
P
97
0027
AXSYM ANTI-HCV (LN 5C36)
P
09
0007
ELECSYS ANTI-HCV IMMUNOASSAY & ELECSYS PRECICONTROL ANTI-HCV FOR USE ON THE ROCHE COBAS E 411 IMMUNOASSAY ANALYZER
P
09
0009
ELECSYS ANTI-HCV IMMUNOASSAY & ELECSYS PRECICONTROL ANTI-HCV FOR USE ON THE MODULAR ANALYTICS E170 IMMUNOASSAY ANALYZER
P
09
0008
ELECSYS ANTI-HCV IMMUNOASSAY & ELECSYS PRECICONTROL ANTI-HCV FOR USE ON THE ROCHE COBAS E 601 IMMUNOASSAY ANALYZER
P
97
0027
AXSYM ANTI-HCV
P
01
0021
ANTI-HCV REAGENT PACK AND CALIBRATOR
P
08
0027
ORAQUICK HCV RAPID ANTIBODY TEST
P
01
0021
VITROS IMMUNODIAGNOSTIC PRODUCT ANTI-HCV REAGENT PACK & CALIBRATOR
P
97
0027
ABBOTT AXSYM ANTI-HCV
P
09
0009
ELECSYS ANTI-HCV IMMUNOASSAY & ELECSYS PRECICONTROL ANTI-HCV FOR USE ON MODULAR ANALYTICS E170 IMMUNOSSAY ANALYZER
P
09
0008
ELECSYS ANTI-HCV IMMUNOASSAY & ELECSYS PRECICONTROL ANTI-HCV FOR USE ON COBAS E601 IMMUNOSSAY ANALYZER
P
09
0007
ELECSYS ANTI-HCV IMMUNOASSAY, ELECSYS PRECICONTROL ANTI-HCV FOR USE ON COBAS E411 IMMUNOSSAY ANALYZER
P
03
0056
ADVIA CENTAUR SOFTWARE V4.0 SP1 ANTI-HCV
P
03
0056
ADVIA CENTAUR XP SOFTWARE V6.0 ANTI-HCV
P
03
0056
ADVIA CENTAUR HCV ON CENTAUR CP
P
01
0021
VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HCV REAGENT PACK AND CALIBRATOR
P
97
0027
ABBOTT AXSYM ANTIBODY TO HCV (ANTI-HCV)
P
05
0042
ARCHITECT ANTI-HCV ASSAY/CALIBRATOR/CONTROL
P
03
0056
ADVIA CENTAUR HCV READYPACK REAGENNTS/QUALITY CONTROL MATERIALS
P
01
0021
VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HCV REAGENT PACK & CALIBRATORS
P
03
0056
ADVIA CENTAUR HCV
P
05
0042
ABBOTT ARCHITECT ANTI-HCV
P
01
0021
VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HCV REAGENT PACK & CALIBRATOR
P
01
0021
VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HCV REAGENT PACK AND CALIBRATOR
P
97
0027
ABBOTT AXSYM ANTI-HCV
P
01
0021
VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HCV REAGENT PACK & CALIBRATORS
P
05
0042
ABBOTT ARCHITECT ANTI-HCV
P
01
0021
VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HCV REAGENT PACK AND VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HCV CALIBRATOR
P
01
0021
VITROS IMMUNODIAGNOSTIC PRODUCTS HCV REAGENT PACK & CALIBRATOR
P
05
0042
ARCHITECT ANTI-HCV
P
97
0027
AXSYM ANTIBODY TO HCV
P
05
0042
ARCHITECT ANTI-HCV REAGENT KITS, ARCHITECT ANTI-HCV CALIBRATORS, AND ARCHITECT ANTI-HCV CONTROLS
P
05
0042
ARCHITECT ANTI-HCV ASSAY; ARCHITECT ANTI-HCV CALIBRATOR; ARCHITECT ANTI-HCV CONTROL
P
01
0021
VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HCV REAGENT PACK AND CALIBRATOR
P
01
0021
VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HCV REAGENT PACK AND CALIBRATOR
P
01
0021
VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HCV REAGENT PACK AND CALIBRATOR
P
01
0021
VITROS IMMUNODIAGNOSTIC ANTI-HCV REAGENT PACK AND CALIBRATOR
P
97
0027
ABBOTT AXSYM ANTI-HCV (LIST NUMBER 5C36)
P
03
0056
ADVIA CENTAUR HCV READY PACK REAGENTS, ADVIA CENTAUR HCV QUALITY CONTROL MATERIALS
P
97
0027
ABBOTT AXSYM ANTI-HCV
P
98
0046
HEPATITS C CHECK TEST SYSTEM
P
97
0027
AXSYM ANTI-HCV
P
01
0021
VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HCV REAGENT PACK & CALIBRATOR
P
01
0021
VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HCV REAGENT PACK AND CALIBRATOR
P
01
0021
VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HCV REAGENT PACK AND CALIBRATORS
P
97
0027
ABBOTT AXSYM ANTI-HCV
P
97
0027
ABBOTT AXSYM ANTIBODY TO HCV
P
98
0046
HOME ACCESS HEPATITIS C CHECK TEST SERVICE
P
01
0021
VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HCV REAGENT PACK & CALIBRATORS
P
98
0046
HOME ACCESS HEPATITIS C TEST SERVICE
P
01
0021
VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HCV REAGENT PACK AND CALIBRATOR
P
98
0046
HOME ACCESS HEPATITIS C CHECK TEST
P
98
0046
HEPATITIS C CHECK TESTING SERVICE
P
98
0046
HOME ACCESS HEPATITIS C CHECK AND HEPATITIS C CHECK EXPRESS
OIH
Yersinia Spp. Reagents
OJN
Mycobacterium Tuberculosis, Cell Mediated Immune Response, Enzyme-Linked Immunospot Test
OJO
Enzyme Linked Immunosorbent Assay For The Detection Of Lipoarabinomannan Antigen Of Mycobacteria
ORL
Whole Blood Pre-Treatment T-Cell Enrichment Reagent
OTT
Research Use Only/Microbiology
OYB
Kit, Rna Detection, Human Papillomavirus
PAB
Cytomegalovirus (Cmv) Dna Quantitative Assay
PCY
Investigational Use Only - Microbiology
POA
Reagents, Zika Virus Nucleic Acid
POG
Reagents, Ebola Zaire Virus (Detected In The West Africa Outbreak In 2014) Nucleic Acid
PYS
Zika Virus Serological Reagents (Emergency Use)
QHV
Multiple Osteoarticular Pathogen Antigen Kit
QIM
Bartonella Spp. Serological Reagents
QIN
Babesia Spp. Serological Reagents
QIO
Anaplasma Spp. And Ehrlichia Spp. Serological Reagents
QIP
Rickettsia Spp. (Spotted Fever Group Or Typhus Group) Serological Reagents
QIQ
Orientia Spp. (Scrub Typhus) Serological Reagents
QJR
Reagents, 2019-Novel Coronavirus Nucleic Acid
QKO
Reagent, Coronavirus Serological
QKP
Coronavirus Antigen Detection Test System.
QLT
Covid-19 Multi-Analyte Respiratory Panel Nucleic Acid Devices
QLW
Covid-19 Test Home Collection Kit Devices
QMN
Covid-19 Multi-Analyte Antigen Device
QSH
Coronavirus Marker Detection
QSN
Orthopedic Infection Microbial Multiplex Nucleic Acid Detection System
QSS
Hiv Self-Tests
QTA
Ngs Whole Genome Sequencing For Sars-Cov-2 Genetic Analysis
QTP
Reagents, Monkeypox Virus Nucleic Acid.
QTQ
Reagents, Non-Variola Orthopoxvirus Nucleic Acid.
QWB
Over-The-Counter Molecular Test To Detect Sars-Cov-2 From Clinical Specimens
QVR
Multiplex Nucleic Acid Detection System For Biothreat Agents
QUU
Simple In Vitro Diagnostic Device For The Detection Of Secreted Proteins From Bacillus Spp. In Human Clinical Samples
QVF
Simple Point-Of-Care Device To Directly Detect Sars-Cov-2 Viral Targets From Clinical Specimens In Near-Patient Settings
QVP
Sars-Cov-2 Serology Test
QWR
Simple Point-Of-Care Device To Detect Sar-Cov-2 Nucleic Acid Targets From Clinical Specimens In Near-Patient Settings
QXA
Lateral Flow Immunochromatography Assay For Host Biomarkers Of Respiratory Infection
QYA
System For Detection Of Nucleic Acid From Non-Viral Microorganism(S) Causing Stis Using Specimens Collected At Home
QYT
Over-The-Counter Covid-19 Antigen Test
QZX
Positive Blood Culture Processor For Inoculum Preparation Used For Antimicrobial Susceptibility Testing
SAN
Automated Antimicrobial Susceptibility Test System For Positive Blood Culture Samples
SBP
Simple Point-Of-Care Nucleic Acid-Based Hepatitis C Virus Ribonucleic Acid Test
SBT
Device To Detect Microbial Colonization Directly From Clinical Specimens.
SBZ
Test For Detection Of Antibodies Associated With Syphilis Performed By Lay Users
SCA
Multi-Analyte Respiratory Virus Antigen Detection Test
SDM
Nucleic Acid Test Used For Screening Of Cadaveric (Non-Heart-Beating) Donors Of Blood Or Blood Products Or Hct/Ps
SDN
Serology Test Used For Screening Of Cadaveric (Non-Heart-Beating) Donors Of Blood Or Blood Products Or Hct/Ps
Submissions with No Product Code
Subpart B—Biological Stains
Subpart B—Clinical Chemistry Test Systems
Subpart B—Diagnostic Devices
Subpart C—Clinical Laboratory Instruments
Subpart C—Microbiology Devices
Subpart D—Serological Reagents
Subpart F—Immunological Test Systems
Neurology
Obstetrical and Gynecological
Ophthalmic
Orthopedic
Pathology
Physical Medicine
Radiology
General and Plastic Surgery
Toxicology
Medical Genetics
Unknown
MI
/
MI-misc
/
MZO
/
P980046
View Source
HOME ACCESS HEPATITIS C CHECK
Page Type
PMA Approval
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
Applicant
PWNHealth Chicago LLC
Trade Name
HOME ACCESS HEPATITIS C CHECK AND HEPATITIS C CHECK EXPRESS
Generic Name
Assay, enzyme linked immunosorbent, hepatitis c virus
Decision Date
4/28/1999
Days to Decision
142 days
Decision Code
APPR
FDA Decision
Approval