Anesthesiology
Review Panel
- CardiovascularReview Panel
- ChemistryReview Panel
- DentalReview Panel
- Ear, Nose, ThroatReview Panel
- Gastroenterology and UrologyReview Panel
- General HospitalReview Panel
- HematologyReview Panel
- ImmunologyReview Panel
- MicrobiologyReview Panel
- MiscellaneousMiscellaneous
- QGNLateral Flow Immunochromatography Assay For Host Infection Biomarkers2Product Code
- PBKNon-Variola Orthopoxvirus Real-Time Pcr Primer And Probe Set2Product Code
- OBFAssay, Genotyping, Hepatitis C Virus3Product Code
- PGHHsv-1 And Hsv-2 Cns Nucleic-Acid Based Panel2Product Code
- QHMSerology Tests Used For Infectious Disease Screening Of Blood And Plasma DonationsUProduct Code
- PQAVaginitis And Bacterial Vaginosis Nucleic Acid Detection System2Product Code
- PRAVariola Virus Nucleic Acid-Based Detection Assay2Product Code
- PRHPositive Blood Culture Identification And Ast Kit2Product Code
- PVQRickettsia Spp. Nucleic Acid Based Detection Assay2Product Code
- PYNFish (Fluorescence In Situ Hybridization) Kit, Nucleic Acid, Plasmodium Sp.2Product Code
- QAACoccidioides Spp. Nucleic Acid Detection System For Respiratory Specimens2Product Code
- QBDMicrobial Nucleic Acid Storage And Stabilization Device2Product Code
- QBNMass Spectrometry, Maldi Tof, Microorganism Identification, Cultured Isolates2Product Code
- QDZQualitative Cytomegalovirus Nucleic Acid-Based Detection Device For Congenital Cytomegalovirus Infection2Product Code
- QEPNucleic Acid Detection System For Non-Viral Microorganism(S) Causing Sexually Transmitted Infections2Product Code
- QFAAssay For Detection Of Proteases In Chronic Wounds2Product Code
- QFOZika Virus Serological Reagents2Product Code
- QHONucleic-Acid Tests Used For Infectious Disease Screening Of Blood And Plasma DonationsUProduct Code
- QIDDevice To Detect Antigens Of Biothreat Microbial Agents In Human Clinical Specimens2Product Code
- QNJMass Spectrometry, Microorganism Identification, Blood Culture2Product Code
- MZPAssay, Hybridization And/Or Nucleic Acid Amplification For Detection Of Hepatitis C Rna,Hepatitis C Virus3Product Code
- NCDTest, Immunity, Cell Mediated, Mycobacterium Tuberculosis3Product Code
- NWYTest, Qualitative, Detection Of Dengue Igm And Igg AntibodiesNProduct Code
- QPODevice To Preserve And Stabilize Relative Abundances Of Microbial Nucleic Acids In Clinical Samples2Product Code
- QQVAutomated System For Sample Preparation And Identification Of Microorganisms From Cultured Isolates By Mass Spectrometry2Product Code
- PZFMers-Cov And Common Respiratory Pathogens Multiplex Nucleic Acid Detection System2Product Code
- QDSMers-Cov And Common Respiratory Pathogens Semi-Quantitative And Quantitative Multiplex Nucleic Acid Detection System2Product Code
- LOMTest, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)3Product Code
- P210003ARCHITECT HBsAg Next Qualitative Reagent Kit, ARCHITECT HBsAg Next Confirmatory Reagent Kit, ARCHITECT HBsAg NEXT QualitAPPRPMA Approval
- P210019ADVIA Centaur Anti-HBc Total (HBcT2) and Atellica IM Anti-HBc Total (HBcT2)APPRPMA Approval
- P200017ADVIA Centaur Anti-HBe2 (aHBe2) assayAPPRPMA Approval
- P190034Elecsys Anti-HBs II, PreciControl Anti-HBs, Anti-HBs CalCheckAPPRPMA Approval
- P190005Elecsys Anti-HBe, PreciControl Anti-HBeAPPRPMA Approval
- P190017LIAISON® XL MUREX HBsAg Qual, LIAISON® MUREX Control HBsAg, and LIAISON® XL MUREX HBsAg Confirmatory TestAPPRPMA Approval
- P180049LIAISON® XL MUREX anti-HBe, LIAISON® XL MUREX Control anti-HBeAPPRPMA Approval
- P180048LIAISON® XL MUREX HBeAg, LIAISON® XL MUREX Control HBeAgAPPRPMA Approval
- P180045LIAISON® XL MUREX HBc IgM, LIAISON® XL MUREX Control HBc IgMAPPRPMA Approval
- P180039LIAISON® XL MUREX Anti-HBs, LIAISON® XL MUREX Control Anti-HBs and LIAISON® XL MUREX Anti-HBs VerifiersAPPRPMA Approval
- P180045LIAISON® XL Murex HBc IgM and LIAISON® XL Murex Control HBc IgM3PMA Approval
- P180039LIAISON® XL Murex Anti-HBs, LIAISON® XL Murex Control Anti-HBs and LIAISON® XL Murex Anti-HBs Verifiers3PMA Approval
- P180038LIAISON® XL Murex Anti-HBc and LIAISON® XL Murex Control Anti-HBc3PMA Approval
- P180049LIAISON® XL Murex Anti-HBe and LIAISON® XL Murex Control Anti-HBe3PMA Approval
- P180048LIAISON® XL Murex HBeAg and LIAISON® XL Murex Control HBeAg3PMA Approval
- P990042ETI-AB-AUK PLUS assay3PMA Approval
- P180039LIAISON® XL Murex Anti-HBs, LIAISON® XL Murex Control Anti-HBs and LIAISON® XL Murex Anti-HBs Verifiers3PMA Approval
- P990043ETI-EBK PLUS assay3PMA Approval
- P990038ETI-MAK-2 PLUS and HBsAg Confirmatory Test assay3PMA Approval
- P180049LIAISON® XL MUREX Anti-HBe and LIAISON® XL MUREX Control Anti-HBe3PMA Approval
- P180045LIAISON® XL MUREX HBc IgM and LIAISON® XL MUREX Control HBc IgM3PMA Approval
- P180038LIAISON® XL Murex Anti-HBc and LIAISON® XL Murex Control Anti-HBc3PMA Approval
- P180048LIAISON® XL MUREX HBeAg and LIAISON® XL MUREX Control HBeAg3PMA Approval
- P180039LIAISON® XL MUREX Anti-HBs, LIAISON® XL MUREX Control Anti-HBs and LIAISON® XL Murex Anti-HBs Verifiers3PMA Approval
- P180045LIAISON® XL MUREX HBc IgM and LIAISON® XL MUREX Control HBc IgM3PMA Approval
- P180038LIAISON® XL MUREX anti-HBc and LIAISON® XL MUREX Control anti-HBc3PMA Approval
- P180048LIAISON® XL MUREX HBeAg and LIAISON® XL MUREX Control HBeAg3PMA Approval
- P180049LIAISON® XL MUREX Anti-HBe and LIAISON® XL MUREX Control Anti-HBe3PMA Approval
- P190034Elecsys Anti-HBs II3PMA Approval
- P160019Elecsys HBsAg II3PMA Approval
- P010054Elecsys Anti-HBs3PMA Approval
- P060035ARCHITECT CORE-M / Alinity i Anti-HBc IgM3PMA Approval
- P080023ARCHITECT CORE / Alinity i Anti-HBc3PMA Approval
- P110029ARCHITECT HBsAg Qualitative/Confirmatory / Alinity i HBsAg Qualitative II/Confirmatory3PMA Approval
- P050051ARCHITECT AUSAB / Alinity i Anti-HBs3PMA Approval
- P160019Elecsys HBsAg Confirmatory Test3PMA Approval
- P050051ARCHITECT AUSAB (LN 1L82)3PMA Approval
- P060035ARCHITECT CORE-M (LN 6L23)3PMA Approval
- P110029ARCHITECT HBsAg Qualitative (LN 4P53), ARCHITECT HBsAg Qualitative Confirmatory (LN 4P54)3PMA Approval
- P080023ARCHITECT CORE (LN 6L22)3PMA Approval
- P190005Elecsys Anti-HBe, PreciControl Anti-HBe3PMA Approval
- P050051Abbott ARCHITECT AUSAB Reagent (100 Test), Abbott ARCHITECT AUSAB Reagent (500 Test), Abbott ARCHITECT AUSAB Reagent, Al3PMA Approval
- P180039LIAISON XL MUREX Anti-HBs, LIAISON XL MUREX Control Anti-HBs and LIAISON XL MUREX Anti-HBs Verifiers3PMA Approval
- P190017LIAISON XL MUREX HBsAg Qual, LIAISON XL MUREX Control HBsAg Qual3PMA Approval
- P180048LIAISON XL MUREX HBeAg, LIAISON XL MUREX Control HBeAg3PMA Approval
- P180049LIAISON XL MUREX Anti-HBe, LIAISON XL MUREX Control Anti-HBe3PMA Approval
- P180038LIAISON XL MUREX Anti-HBc, LIAISON XL MUREX Control Anti-HBc3PMA Approval
- P180045LIAISON XL MUREX HBc IgM, LIAISON XL MUREX Control HBc IgM3PMA Approval
- P200017ADVIA Centaur Anti-HBe2 (aHBe2) assay3PMA Approval
- P010050IMMULITE 2000 HBs Ag Confirmatory3PMA Approval
- P060035ARCHITECT CORE-M Reagent Kit, Alinity i Anti-HBc IgM Reagent Kit3PMA Approval
- P030040Atellica IM Hepatitis B core IgM (aHBcM) Assay3PMA Approval
- P040004Atellica IM Anti-Hepatitis B core Total (HBcT) Assay3PMA Approval
- P090024Atellica IM Hepatitis B e Antigen (HBeAg) Assay3PMA Approval
- P100039Atellica IM Anti-Hepatitis B surface Antigen 2 (aHBs2) Assay3PMA Approval
- P110041Atellica IM Hepatitis B surface Antigen II (HBsll), Atellica IM Hepatitis B surface Antigen 11 Confirmatory (HBsll Conf)3PMA Approval
- P050051ARCHITECT AUSAB Reagent, ARCHITECT AUSAB Reagent Kit, Alinity i Anti-HBs Reagent Kit3PMA Approval
- P080023ARCHITECT CORE Reagent Kit, Alinity i Anti-HBc Reagent Kit3PMA Approval
- P110029ARCHITECT HBsAg Qualitative Reagent, ARCHITECT HBsAg Qualitative Confirmatory Reagent, Alinity i HBsAg Qualitative II Re3PMA Approval
- P060035ARCHITECT CORE-M Reagent Kit, Alinity i Anti-HBc IgM Reagent Kit3PMA Approval
- P100039ADVIA Centaur aHBs2 Assay3PMA Approval
- P030049ADVIA Centaur HBsAg ReadyPack Reagents/ADVIA Centaur HBsAg Confirmatory ReadyPack Reagents, ADVIA Centaur HBsAg Quality3PMA Approval
- P110041ADVIA Centaur HBsAg II(HBsII), ADVIA Centaur HBsAg Confirmatory, ADVIA Centaur HBsAg Quality Control Material, Atellica3PMA Approval
- P040004ADVIA Centaur HBc Total ReadyPack Reagents, ADVIA Centaur HBc Total Quality Control Materials, Atellica IM Anti-Hepatiti3PMA Approval
- P010051IMMULITE 2000/2000 XPi Anti-HBc3PMA Approval
- P100039ADVIA Centaur anti-HBs2 (aHBs2), ADVIA Centaur Anti-HBs2 (aHBs2) Quality Control Material, Atellica IM Anti-Hepatitis B3PMA Approval
- P030040ADVIA Centaur Hepatitis B Core Antigen (aHBcM) Assay, Atellica IM Hepatitis B Core Antigen (aHBcM) Assay, Atellica IM He3PMA Approval
- P010053IMMULITE 2000/2000 XPi Anti-HBc IgM3PMA Approval
- P190034Elecsys Anti-HBs II, PreciControl Anti-HBs, Anti-HBs CalCheck3PMA Approval
- P190005Elecsys Anti-HBe, PreciControl Anti-HBe3PMA Approval
- P050051ARCHITECT AUSAB and Alinity i Anti-HBs3PMA Approval
- P000014VITROS Immunodiagnostic Products Anti-HBs Quantitative Reagent Pack and Calibrator3PMA Approval
- P160019Elecsys HBsAg II Auto Confirm3PMA Approval
- P010053IMMULITE 2000 Anti-HBcM3PMA Approval
- P010051IMMULITE 2000 Anti-HBc3PMA Approval
- P010050IMMULITE 2000 HBsAg Confirmatory3PMA Approval
- P010052IMMULITE 2000 Anti-HBs3PMA Approval
- P190017LIAISON® XL MUREX HBsAg Qual, LIAISON® MUREX Control HBsAg, and LIAISON® XL MUREX HBsAg Confirmatory Test3PMA Approval
- P180049LIAISON® XL MUREX anti-HBe, LIAISON® XL MUREX Control anti-HBe3PMA Approval
- P180048LIAISON® XL MUREX HBeAg, LIAISON® XL MUREX Control HBeAg3PMA Approval
- P180045LIAISON® XL MUREX HBc IgM, LIAISON® XL MUREX Control HBc IgM3PMA Approval
- P110041ADVIA Centaur HBsAgII/Confirmatory Readypack Reagents and QC Material3PMA Approval
- P030049ADVIA Centaur HBsAg/Confirmatory Readypack Reagents, Calibrators and Controls3PMA Approval
- P100039ADVIA Centaur aHBs2 Readypack Reagents and Quality Control Materials3PMA Approval
- P040004ADVIA Centaur HBc Total Readypack Reagents and Quality COntrol Materials3PMA Approval
- P030040ADVIA Centaur HBc IgM Readypack Reagents and Quality Control Material3PMA Approval
- P090024ADVIA Centaur HBeAg Readypack Reagents and Quality Control Material3PMA Approval
- P990043ETI-EBK PLUS assay3PMA Approval
- P990042ETI-AB-AUK PLUS assay3PMA Approval
- P180038LIAISON XL Murex Anti-HBc and LIAISON XL Murex Control Anti-HBc3PMA Approval
- P990038ETI-MAK-2 PLUS and HBsAg Confirmatory Test assays3PMA Approval
- P180039LIAISON XL Murex Anti-HBs, LIAISON XL Murex Control Anti-HBs and LIAISON XL Murex Anti-HBs Verifiers3PMA Approval
- P180038LIAISON XL MUREX Anti-HBc3PMA Approval
- P180039LIAISON XL MUREX Anti-HBs3PMA Approval
- P110029ARCHITECT HBsAg Qualitative Reagent Kit, ARCHITECT HBsAg Qualitative Reagent Kit, ARCHITECT HBsAg Qualitative Confirmato3PMA Approval
- P050051Alinity i Anti-HBs Reagent Kit3PMA Approval
- P060035Alinity i Anti-HBc IgM Reagent Kit3PMA Approval
- P080023Alinity i Anti-HBc Reagent Kit3PMA Approval
- P110029Alinity i HBsAg Qualitative II Reagent Kit and Alinity i HBsAg Qualitative II Confirmatory Kit3PMA Approval
- P110029Alinity i HBsAg Qualitative II3PMA Approval
- P050051ARCHITECT AUSAB3PMA Approval
- P110029ARCHITECT HBsAg Qualitative/Confirmatory3PMA Approval
- P060035ARCHITECT CORE-M3PMA Approval
- P080023ARCHITECT CORE3PMA Approval
- P080023Alinity i Anti-HBc3PMA Approval
- P050051Alinity i Anti-HBs3PMA Approval
- P060035Alinity i Anti-HBc lgM3PMA Approval
- P180038LIAISON XL MUREX anti-HBc3PMA Approval
- P030040Atellica IM Hepatitis B core IgM (aHBcM) Assay3PMA Approval
- P040004Atellica IM Anti-Hepatitis B core Total (HBcT) Assay3PMA Approval
- P090024Atellica IM Hepatitis B e Antigen (HBeAg) Assay3PMA Approval
- P100039Atellica IM Anti-Hepatitis B surface Antigen 2 (aHBs2)Assay3PMA Approval
- P110041Atellica IM Hepatitis B surface Antigen II (HBs11) and Atellica IM Hepatitis B surface Antigen 11 confirmatory (HBs11 Co3PMA Approval
- P110041ADVIA Centaur and Atellica IM HBsAgII3PMA Approval
- P090024ADVIA Centaur and Atellica IM HBeAg3PMA Approval
- P030049ADVIA Centaur HBsAg3PMA Approval
- P040004ADVIA Centaur and Atellica IM HBc Total3PMA Approval
- P100039ADVIA Centaur and Atellica IM Anti-HBs2 (aHBs2)3PMA Approval
- P030040ADVIA Centaur and Atellica IM HBc IgM3PMA Approval
- P160019Elecsys HBsAg II, Elecsys HBsAg Confirmatory Test, and PreciControl HBsAg II3PMA Approval
- P180039LIAISON® XL MUREX Anti-HBs, LIAISON® XL MUREX Control Anti-HBs and LIAISON® XL MUREX Anti-HBs Verifiers3PMA Approval
- P110029Alinity i HBsAg Qualitative II, Alinity i HBsAg Qualitative Confirmatory3PMA Approval
- P180038LIAISON XL MUREX Anti-HBc, LIAISON MUREX Control Anti-HBc3PMA Approval
- P010050IMMULITE 2000 HBsAg & HBs Ag Confirmatory3PMA Approval
- P010052IMMULITE 2000 Anti-HBs3PMA Approval
- P010051IMMULITE 2000 Anti-HBc3PMA Approval
- P010053IMMULITE 2000 Anti HBc IgM3PMA Approval
- P050051ARCHITECT AUSAB, LN 1L823PMA Approval
- P030049ADVIA Centaur HBsAg3PMA Approval
- P990038ETI MAK-2 PLUS Assay and HBsAg Confirmatory Test3PMA Approval
- P990042ETI-AB-AUK PLUS assay3PMA Approval
- P990043ETI-EBK PLUS Aassay3PMA Approval
- P990043ETI-EBK Plus Assay3PMA Approval
- P990042ETI-AB-AUK Plus Assay3PMA Approval
- P990038ETI-MAK-2 Plus Assay3PMA Approval
- P050051ARCHITECT AUSAB3PMA Approval
- P060035Alinity i Anti-HBc IgM Reagent Kit, Alinity i Anti-HBc IgM Calibrators, Alinity i Anti-HBc IgM Controls3PMA Approval
- P100001VITROS Anti-HBe3PMA Approval
- P000044VITROS HBsAg3PMA Approval
- P090028VITROS HBeAg3PMA Approval
- P030026VITROS Anti-HBc IgM3PMA Approval
- P030024VITROS Anti-HBc3PMA Approval
- P000014VITROS Anti-HBs3PMA Approval
- P100032Elecsys Anti-HBc II3PMA Approval
- P110025Elecsys Anti-HBc IgM3PMA Approval
- P110031Elecsys Anti-HBc IgM3PMA Approval
- P010054Elecsys Anti-HBs3PMA Approval
- P110022Elecsys Anti-HBc IgM3PMA Approval
- P100031Elecsys Anti-HBc II3PMA Approval
- P990012Elecsys HBsAg Immunoassay3PMA Approval
- P160019Elecsys HBsAg II3PMA Approval
- P010054Elecsys Anti-HBs; PreciControl Anti-HBs; Anti-HBs CalCheck3PMA Approval
- P110041Atellica IM Hepatitis B surface Antigen II (HBsII( and Atellica IM Hepatitis B surface Antigen 1 1 Comfirmatory *HBs11 C3PMA Approval
- P090024Atellica IM Hepatitis B e Antigen (HBeAg) Assay3PMA Approval
- P040004Atellica Im Anti-Hepatitis B core Total (HBcT) Assay3PMA Approval
- P030040Atellica IM Hepatitis B orfe IgM (aHBcM) Assay3PMA Approval
- P100039Atellica IM Anti-Hepatitis B surface Antigen 2 (aHBs2) Assay3PMA Approval
- P080023Alinity i Anti-HBc Reagent Kit, Alinity i Anti-HBc Calibrator, Alinity i Anti-HBc Controls3PMA Approval
- P050051Alinity i Anti-HBs Regent Kit, Alinity i Anti-HBs Calibrators, and Alinity i Anti-HBs Controls3PMA Approval
- P030026VITROS Immunodiagnostic Products Anti-HBc IgM Reagent Pack and Calibrator3PMA Approval
- P030024VITROS Immunodiagnostic Products Anti-HBc Reagent Pack and Calibrator3PMA Approval
- P000044VITROS Immunodiagnostic Products HBsAg Reagent Pack, Calibrator and Confirmatory Kit3PMA Approval
- P000014VITROS Immunodiagnostic Products Anti-HBs Quantitative Reagent Pack and Calibrator3PMA Approval
- P100001VITROS Immunodiagnostic Products Anti-HBe Reagent Pack and Calibrator3PMA Approval
- P090028VITROS Immunodiagnostic Products HBeAg Reagent Pack and Calibrator3PMA Approval
- P060035ARCHITECT CORE-M (LN 6l23), Calibrators, Controls and Reagent Kit3PMA Approval
- P110029ARCHITECT HBsAg Qualitative (LN 4P53) and HBsAg Qualitative Confirmatory (LN 4P54)3PMA Approval
- P050051ARCHITECT AUSAB (LN 1L82)3PMA Approval
- P080023ARCHITECT CORE (LN 6L22)3PMA Approval
- P100032Elecsys Anti-HBc II3PMA Approval
- P110022Elecsys Anti-HBc IgM3PMA Approval
- P130015Elecsys HBeAg3PMA Approval
- P110025Elecsys Anti-HBc IgM3PMA Approval
- P110031Elecsys Anti-HBc IgM3PMA Approval
- P160019Elecsys HBsAg II (100/200 tests)3PMA Approval
- P010054Elecsys ANti-HBs3PMA Approval
- P100031Elecsys Anti-HBc II3PMA Approval
- P030024VITROS Immunodiagnostic Products Anti-HBc Reagent Pack and Calibrator3PMA Approval
- P040004Atellica IM anti-HBc Total (HBcT)3PMA Approval
- P110041Atellica IM HBsAgII (HBsII)/Atellica IM HBsAg Confirmatory3PMA Approval
- P100039Atellica IM Anti-Hepatitis B Surface Antigen 2 (aHBs2)3PMA Approval
- P090024Atellica IM Hepatitis B e Antigen (HBeAg)3PMA Approval
- P030040Atellica IM Hepatitis B core IgM (aHBcM)3PMA Approval
- P030040Atellica IM Hepatitis B core IgM (aHBcM) assay; Atellica IM Hepatitis B core lgM Quality Control (aHBcM QC)3PMA Approval
- P080023ARCHITECT CORE, LN 6L223PMA Approval
- P110029ARCHITECT HBsAG Qualitative Reagent Kit (100/500 Test), ARCHITECT HBsAG Qualitative Confirmatory Reagent Kit3PMA Approval
- P010054Elecsys Ani-HBs, PreciControl Anti-HBs and Anti-HBs CalCheck3PMA Approval
- P090024Atellica IM Hepatitis B e Antigen (HBeAg)3PMA Approval
- P040004Atellica IM Anti-Hepatitis B core Total (HBcT), Atellica IM Anti-Hepatitis B core Total Quality Control (HBcT QC)3PMA Approval
- P100001VITROS Immunodiagnostic Products Anti-HBe Reagent Pack and Calibrator3PMA Approval
- P030026VITROS Immunodiagnostic Products Anti-HBc IgM Reagent Pack and Calibrator3PMA Approval
- P000014VITROS Immunodiagnostic Products Anti-HBs Quantitative Reagent Pack and Calibrator3PMA Approval
- P030024VITROS Immunodiagnostic Products Anti-HBc Reagent Pack and Calibrator3PMA Approval
- P090028VITROS Immunodiagnostic Products HBeAg Reagent Pack and Calibrator3PMA Approval
- P000044VITROS Immunodiagnostic Products HBsAg Reagent Pack, Calibrator and Confirmatory Kit3PMA Approval
- P090028VITROS Immunodiagnostic Products HBeAg Reagent Pack and Calibrator3PMA Approval
- P000014VITROS Immunodiagnostic Products Anti-HBs Quantitative Reagent Pack and Calibrator3PMA Approval
- P100001VITROS Immunodiagnostic Products Anti-HBe Reagent Pack and Calibrator3PMA Approval
- P000044VITROS Immunodiagnostic Products HBsAg Reagent Pack, Calibrator and Confirmatory Kit3PMA Approval
- P030026VITROS Immunodiagnostic Products Anti-HBc IgM Reagent Pack and Calibrator3PMA Approval
- P030024VITROS Immunodiagnostic Products Anti-HBc Reagent Pack and Calibrator3PMA Approval
- P990043ETI-EBK PLUS Assay3PMA Approval
- P990038ETI-MAK-2 PLUS, HBsAg Confirmatory Test Assays3PMA Approval
- P990042ETI-AB-AUK PLUS Assay3PMA Approval
- P990012Elecsys HBsAg Immunoassay3PMA Approval
- P130015Elecsys HBcAg3PMA Approval
- P110022Elecsys Anti-HBc IgM3PMA Approval
- P100031Elecsys Anti-HBc II3PMA Approval
- P160019Elecsys HBsAg II3PMA Approval
- P010054Elecsys Anti-HBs3PMA Approval
- P110041Advia Centaur HBsll3PMA Approval
- P100039Atellica IM Anti-Hepatitis B surface Antigen 2 (aHBs2), Atellica IM Anti-Hepatitis B surface Antigen 2 Quality Control (3PMA Approval
- P010054Elecsys Anti-HBs, PreciControl Anti-HBs and Anti-HBs CalCheck3PMA Approval
- P030040Atellica IM Hepatitis B core Antigen (aHBcM)3PMA Approval
- P990038ETI-MAK-2 PLUS and HBsAg Confirmatory Test Assays3PMA Approval
- P990042ETI-AB-AUK PLUS Assay3PMA Approval
- P990043ETI-EBK PLUS Assay3PMA Approval
- P100032Elecsys Anti-HBc II3PMA Approval
- P110031Elecsys Anti-HBc IgM3PMA Approval
- P990012Elecsys HBsAg Immunoassay3PMA Approval
- P010054Elecsys Anti-HBs Immunoassay3PMA Approval
- P100031Elecsys Anti-HBc II3PMA Approval
- P110041ADVIA Centaur HBsAgII (HBsII), ADVIA Centaur HBsAg Confirmatory, ADVIA Centaur HBsAg Quality Control3PMA Approval
- P990043ETI-EBK PLUS Assay3PMA Approval
- P990042ETI-AB-AUK PLUS Assay3PMA Approval
- P990038ETI-MAK-2 PLUS and HBsAg Confirmatory Test Assays3PMA Approval
- P130015Elecsys HBeAg and PreciControl HBeAg3PMA Approval
- P030026VITROS Immunodiagnostic Products Anti-HBc IgM Reagent Pack and Calibrator3PMA Approval
- P090028HBeAg Reagent Pack and Calibrator3PMA Approval
- P100001Vitros Immunodiagnostic Products Anti-HBe Reagent Pack and Calibrator3PMA Approval
- P100031Elecsys Anti-HBc II, PreciControl Anti-HBc3PMA Approval
- P160019Elecsys HBsAg II/Elecsys HBsAg Confirmatory Test/ PreciControl HBsAg II3PMA Approval
- P160019Elecsys HBsAg II/Elecsys HBsAg Confirmatory Test/ PreciControl HBsAg II3PMA Approval
- P110022Elecsys Anti-HBc IgM and PreciControl Anti-HBc IgM3PMA Approval
- P100031Elecsys Anti-HBc II3PMA Approval
- P110031Elecsys Anti-HBc IgM3PMA Approval
- P990012Elecsys HBsAg Immunoassay3PMA Approval
- P110025Elecsys Anti-HBc IgM3PMA Approval
- P010054Elecsys Anti-HBs3PMA Approval
- P160019Elecsys HBsAg II3PMA Approval
- P130015Elecsys HBeAg3PMA Approval
- P100032Elecsys Anti-HBc II3PMA Approval
- P110022Elecsys Anti-HBc IgM3PMA Approval
- P000044Vitros Immunodiagnostic Products HBs Ag Reagent Pack and Calibrator3PMA Approval
- P160019Elecsys HBsAg II/Elecsys HBsAg Confirmatory Test/ PreciControl HBsAg II3PMA Approval
- P090028VITROS Immunodiagnostic Products HBeAg Reagent Pack / VITROS Immunodiagnostic Products HBeAg Calibrator3PMA Approval
- P990038ETI MAK-2 PLUS and HBsAg Confirmatory Test assays3PMA Approval
- P990043ETI-EBK PLUS assay3PMA Approval
- P990042ETI-AB-AUK PLUS assay3PMA Approval
- P110029ARCHITECT HBSAG QUALITATIVE, QUALITATIVE CONFIRMATORY, CONFIRMATORY MANUAL DILUENT, CALIBRATORS, AND CONTROLS3PMA Approval
- P100001VITROS Immunodiagnostic Products Anti-HBe Reagent Pack and Calibrator3PMA Approval
- P090028VITROS IMMUNODIAGNOSTIC PRODUCTS HBEAG REAGENT PACK/PRODUCTS HBEAG CALIBRATOR/PRODUCTS HBE CONTROLS3PMA Approval
- P100001VITROS ANTI-HBE REAGENT PACK/ANTI-HBE CALIBRATOR/ANTI HBE CONTROLS3PMA Approval
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- P030024VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC REAGENT PACK & CALIBRATORS3PMA Approval
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- P050051ABBOTT ARCHITECT3PMA Approval
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- P060034BIO RAD MONOLISA ANTI-HBC IGM EIA3PMA Approval
- P060031BIO-RAD MONOLISA ANTI-HBC EIA3PMA Approval
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- P010054ELECSYS ANTI-HBS IMMUNOASSAY AND ELECSYS PRECICONTROL ANTI-HBS3PMA Approval
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- P060009AXSYM CORE-M 2.0 & AXSYM CORE-M 2.0 CONTROLS3PMA Approval
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- P060012AXSYM CORE 2.0 AND AXSYM CORE 2.0 CONTROLS3PMA Approval
- P060007ARCHITECT HBSAG REAGENT KIT, CALIBRATORS, CONTROLS, CONFIRMATORY REAGENT KIT, CONFIRMATORY MANUAL DILUENT3PMA Approval
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- P010054ELECSYS ANTI-HBS IMMUNOASSAY TEST SYSTEM3PMA Approval
- P000044VITROS IMMUNODIAGNOSTIC HBSAG REAGENT PACK CALIBRATOR AND CONFIRMATORY KIT3PMA Approval
- P010054ELECSYS AND HBS IMMUNOASSAY AND ELECSYS PRECICONTROL ANTI-HBS3PMA Approval
- P010051IMMULITE/IMMULITE 1000 AND IMMULITE 2000 ANTI-HBC ASSAYS3PMA Approval
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- P030024VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC REAGENT PACK AND CALIBRATOR3PMA Approval
- P000044VITROS IMMUNODIAGNOSTIC PRODUCTS HBSAG REAGENT PACK AND CALIBRATOR & PRODUCTS HBSAG CONFIRMATORY KIT3PMA Approval
- P000014VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBS REAGENT PACK AND CALIBRATOR3PMA Approval
- P050051ABBOTT ARCHITECT AUSAB3PMA Approval
- P050049AXSYM HBSAG, HBSAG CONFIRMATORY, AND AXSYM HBSAG CONTROLS3PMA Approval
- P990038ETI-MAK-2 PLUS3PMA Approval
- P000044VITROS IMMUNODIAGNOSTIC PRODUCTS HBSAG REAGENT PACK AND CALIBRATOR, AND HBSAG CONFIRMATORY KIT3PMA Approval
- P000014IMMUNODIAGNOSTIC PRODUCTS ANTI-HBS REAGENT PACK AND CALIBRATOR3PMA Approval
- P000044VITROS IMMUNODIAGNOSTIC PRODUCTS HBSAG REAGENT PACK AND CALIBRATOR3PMA Approval
- P030026VITROS IMMUNODIAGNOSTIC PRODICTS ANTI-HBC IGM REAGENT PACK AND CALIBRATOR3PMA Approval
- P030024VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC REAGENT PACK AND CALIBRATOR3PMA Approval
- P000044VITROS IMMUNODIAGNOSTIC PRODUCTS HBSAG REAGENT PACK AND CALIBRATORS3PMA Approval
- P990012ELECSYS HBSAG TEST SYSTEM3PMA Approval
- P010052IMMULITE/IMMULITE 1000 AND IMMULITE 2000 ANTI-HBS3PMA Approval
- P010051IMMULITE/IMMULITE 1000 AND IMMULITE 2000 ANTI-HBC3PMA Approval
- P010053IMMULITE/IMMULITE 1000 AND IMMULITE 2000 ANTI-HBC IGM3PMA Approval
- P030026VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC IGM REAGENT PACK AND CALIBRATOR3PMA Approval
- P010054ELECSYS ANTI-HBS,ELECSYS PRECICONTROL ANTI-HBS3PMA Approval
- P000044VITROS IMMUNODIAGNOSTIC PRODUCTS HBSAG REAGENT PACK & CALIBRATORS3PMA Approval
- P990012ELECSYS HBSAG IMMUNOASSAY, ELECSYS HBSAG CONFIRMATORY TEST AND ELECSYS PRECICONTROL HBSAG3PMA Approval
- P990045ETI-AB-COREK PLUS3PMA Approval
- P000044VITROS IMMUNODIAGNOSTIC PRODUCTS HBSAG REAGENT PACK AND CALIBRATOR/CONFIRMATORY KIT3PMA Approval
- P030026VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC IGM REAGENT PACK & CALIBRATORS3PMA Approval
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- P990043DIASORIN ETI-EBK PLUS3PMA Approval
- P990041DIASORIN ETI-AB-EBK PLUS3PMA Approval
- P990044DIASORIN ETI-CORE-IGMK PLUS3PMA Approval
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- P030049ADVIA CENTAUR HBSAG READY PACK REAGENTS/CONFIRMATORY READY PACK REAGENTS/QUALITY CONTROL MATERIAL3PMA Approval
- P000014VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBS REAGENT PACK AND CALIBRATORS3PMA Approval
- P030024VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC REAGENT PACK AND CALIBRATOR3PMA Approval
- P000044VITROS IMMUNODIAGNOSTIC PRODUCTS HBSAG REAGENT PACK AND CALIBRATOR AND THE VITROS IMMUNODIAGNOSTIC PRODUCTS HBSAG CONFIR3PMA Approval
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- P000014VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HB REAGENT PACK & CALIBRATORS3PMA Approval
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- P030026VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC IGM REAGENT PACK AND CALIBRATORS3PMA Approval
- P040004ADVIA CENTAUR HBC TOTAL READYPACK REAGENTS/ADVIA CENTAUR HBC TOTAL QUALITY CONTROL MATERIALS3PMA Approval
- P000044VITROS IMMUNODIAGNOSTIC PRODUCTS HBSAG REAGENT PACK AND CALIBRATOR AND THE VITROS IMMUNODIAGNOSTIC PRODUCTS HBSAG CONFIR3PMA Approval
- P000044VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBSAG REAGENT PACK AND CALIBRATOR3PMA Approval
- P030026VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC IGM REAGENT PACK AND CALIBRATOR3PMA Approval
- P030024VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC REAGENT PACK & CALIBRATOR3PMA Approval
- P000014VITROS IMMUNODIAGNOSTIC ANTI-HBS REAGENT PACK AND CALIBRATOR3PMA Approval
- P000014VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBS QUANTITATIVE REAGENT PACK, VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBS CALIBRATS3PMA Approval
- P030040ADVIA CENTAUR HBC IGM READYPACK REAGENTS, ADVIA CENTAUR HBC IGM QUALITY CONTROL MATERIALS3PMA Approval
- P000014VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBS REAGENT PACK AND CALIBRATORS3PMA Approval
- P030026VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC IGM REAGENT PACK AND CALIBRATOR3PMA Approval
- P990038DIASORIN ETI-MAK-2 PLUS3PMA Approval
- P000014VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBS REAGENT PACK AND CALIBRATORS3PMA Approval
- P030029ADVIA CENTAUR ANTI-HBS READYPACK REAGENTS AND CALIBRATORS3PMA Approval
- P990038DIASORIN ETI-MAK-2-PLUS3PMA Approval
- P990038DIASORIN ETI-MAK-2 PLUS3PMA Approval
- P990044DIASORIN ETI-CORE-IGMK PLUS3PMA Approval
- P990045DIASORIN ETI-AB-COREK PLUS3PMA Approval
- P990043DIASORIN ETI-EBK PLUS3PMA Approval
- P990042DIASORIN ETI-AB-AUK PLUS3PMA Approval
- P990041DIASORIN ETI-AB-EBK PLUS3PMA Approval
- P030024VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC REAGENT PACK AND CALIBRATOR3PMA Approval
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- P030026VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC IGM REAGENT PAK/CALIBRATOR3PMA Approval
- P030024VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC REAGENT PACK/CALIBRATOR3PMA Approval
- P990041DIASORIN ETI-AB-EBK PLUS ASSAY3PMA Approval
- P990043DIASORIN ETI-EBK PLUS ASSAY3PMA Approval
- P990045DIASORIN ETI-AB-COREK PLUS ASSAY3PMA Approval
- P990038DIASORIN ETI-MAK-2 PLUS ASSAY3PMA Approval
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- P990042ETI-AB-AUK PLUS3PMA Approval
- P990043ETI-EBK PLUS3PMA Approval
- P990044ETI-CORE-IGMK PLUS3PMA Approval
- P990045ETI-AB-COREK PLUS3PMA Approval
- P010050IMMULITE/ IMMULITE 1000 AND IMMULITE 2000 HBSAG KITS.3PMA Approval
- P990041ETI-AB-EBK PLUS3PMA Approval
- P990044DIASORIN ETI-CORE-IGMK PLUS3PMA Approval
- P000044VITROS IMMUNODIAGNOSTIC PRODUCTS HBSAG REAGENT PACK/ CALIBRATOR3PMA Approval
- P990038DIASORIN HBSAG CONFIRMATORY TEST3PMA Approval
- P010052IMMULITE, IMMULITE 1000 ANTI-HBS AND IMMULITE 2000 ANTI-HBS3PMA Approval
- P010050IMMULITE,IMMULITE 1000 HBSAG,CONFIRMATORY AND IMMULITE 2000 HBSAG,CONFIRMATORY KIT3PMA Approval
- P010053IMMULITE, IMMULITE 1000 ANTI-HBC AND IMMULITE 2000 ANTI-HBC3PMA Approval
- P010051IMMULITE, IMMULITE 1000 ANTI-HBC IGM AND IMMULITE 2000 ANTI-HBCIGM3PMA Approval
- P000014VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBS REAGENT/ANTI-HBS CALIBRATORS3PMA Approval
- P790025ABBOTT HBE (RDNA) EIA3PMA Approval
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- P990042ETI-AB-AUK PLUS ASSAY3PMA Approval
- P990041DIASORIN ETI-AB-EBK PLUS3PMA Approval
- P990044DIASORIN ETI-CORE-IGMK PLUS3PMA Approval
- P990045ETI-AB-COREK PLUS3PMA Approval
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- P990038DIASORIN ETI-MAK-2 PLUS3PMA Approval
- P010050IMMULITE 2000 XPI HBSAG3PMA Approval
- P010053IMMULITE 2000 XPI ANTI-HBC IMG3PMA Approval
- P010051IMMULITE 2000 XPI ANTI-HBC3PMA Approval
- P010052IMMULITE 2000 XPI ANTI-HBS3PMA Approval
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- P990043ETI-EBK PLUS3PMA Approval
- P990041DIASORIN ETI-AB-EBK PLUS3PMA Approval
- P990045ETI-AB-COREK PLUS3PMA Approval
- P990038ETI-MAK-2 PLUS3PMA Approval
- P990044ETI-CORE-IGMK PLUS3PMA Approval
- P990042ETI-AB-AUK PLUS3PMA Approval
- P010054ELECSYS ANTI-HBS3PMA Approval
- P990042ETI-AB-AUK PLUS ASSAY3PMA Approval
- P000014VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBS REAGENT PACK/CALIBRATORS3PMA Approval
- P000044VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBSAG REAGENT PACK, CALIBRATORS, AND CONFIRMATORY KIT3PMA Approval
- P990012ELECSYS HBSAG IMMUNOASSAY, ELECSYS HBSAG CONFIRMATORY, AND PRECICONTROL HBSAG3PMA Approval
- P000044VITROS IMMUNODIAGNOSTIC PRODUCTS HBS AG REAGENT PACK/CALIBRATOR/CONFIRMATORY KIT3PMA Approval
- P000044VITROS IMMUNODIAGNOSTIC PRODUCTS/HBSAG REAGENT PACK,VITROS IMMUNODIAGNOSTIC PRODUCTS CONFIRMATORY KIT, AND VITROS IMMUNR3PMA Approval
- P000014VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBS REAGENT PACK & CALIBRATORS3PMA Approval
- P000014VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBS REAGENT PACK & CALIBRATORS3PMA Approval
- P990042DIASORIN ETI-AB-AUK PLUS ASSAY3PMA Approval
- P990038DIASORIN ETI MAK-2 PLUS ASSAY3PMA Approval
- P000014VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBS REAGENT PACK/CALIBRATORS3PMA Approval
- P990043DIASORIN ETI-EBK PLUS ASSAY3PMA Approval
- P870048EBK RIA ASSAY/ETI-EBK3PMA Approval
- P000014VITROS IMMUNODIAGNOSTIC PRODUCTS:ANTI-HBS REAGENT PACK/ANTI-HBS CALIBRATORS3PMA Approval
- P790025ABBOTT HBE (RDNA) EIA3PMA Approval
- P790025ABBOTT HBE (RDNA) EIA TEST KIT3PMA Approval
- P870048EBK3PMA Approval
- P870048EBK3PMA Approval
- P840070HEPANOSTIKA(TM) HBEAG/ANTI HBE MICROELISA(TM) SYST3PMA Approval
- P850044AB-CORE K HEPATITIS B CORE ANTIGEN 125I3PMA Approval
- P790025ABBOTT HBE DIAGNOSTIC KIT3PMA Approval
- P850044AB-CORE K HEPATITIS B CORE ANTIGEN 125I3PMA Approval
- P850044AB-CORE K HEPATITIS B CORE ANTIGEN 125I3PMA Approval
- P840070HEPANOSTIKA(TM) HBEAG/ANTI HBE MICROELISA(TM) SYST3PMA Approval
- P780016CORAB3PMA Approval
- P830014CORAB-M3PMA Approval
- P780016CORAB3PMA Approval
- P790025HBE RIA DIAGNOSTIC KIT3PMA Approval
- P790025ABBOTT HBE DIAGNOSTIC KIT3PMA Approval
- P790025ABBOTT HBE DIAGNOSTIC KIT3PMA Approval
- P780016CORAB3PMA Approval
- P780016CORAB3PMA Approval
- LQIHepatitis Delta Serological Reagents3Product Code
- MAQKit, Dna Detection, Human Papillomavirus3Product Code
- MHRTest, Anti-Tumor Cell Susceptibility3Product Code
- MKTHepatitis Viral B Dna Detection3Product Code
- MYLAssay,Enzyme Linked Immunosorbent,Parvovirus B19 Igg3Product Code
- MYMAssay,Enzyme Linked Immunosorbent,Parvovirus B19 Igm3Product Code
- MZOAssay, Enzyme Linked Immunosorbent, Hepatitis C Virus3Product Code
- OIHYersinia Spp. ReagentsUProduct Code
- OJNMycobacterium Tuberculosis, Cell Mediated Immune Response, Enzyme-Linked Immunospot Test3Product Code
- OJOEnzyme Linked Immunosorbent Assay For The Detection Of Lipoarabinomannan Antigen Of MycobacteriaNProduct Code
- ORLWhole Blood Pre-Treatment T-Cell Enrichment Reagent3Product Code
- OTTResearch Use Only/MicrobiologyNProduct Code
- OYBKit, Rna Detection, Human Papillomavirus3Product Code
- PABCytomegalovirus (Cmv) Dna Quantitative Assay3Product Code
- PCYInvestigational Use Only - MicrobiologyNProduct Code
- POAReagents, Zika Virus Nucleic AcidNProduct Code
- POGReagents, Ebola Zaire Virus (Detected In The West Africa Outbreak In 2014) Nucleic AcidNProduct Code
- PYSZika Virus Serological Reagents (Emergency Use)NProduct Code
- QHVMultiple Osteoarticular Pathogen Antigen KitNProduct Code
- QIMBartonella Spp. Serological ReagentsNProduct Code
- QINBabesia Spp. Serological ReagentsNProduct Code
- QIOAnaplasma Spp. And Ehrlichia Spp. Serological ReagentsNProduct Code
- QIPRickettsia Spp. (Spotted Fever Group Or Typhus Group) Serological ReagentsNProduct Code
- QIQOrientia Spp. (Scrub Typhus) Serological ReagentsNProduct Code
- QJRReagents, 2019-Novel Coronavirus Nucleic AcidNProduct Code
- QKOReagent, Coronavirus SerologicalNProduct Code
- QKPCoronavirus Antigen Detection Test System.NProduct Code
- QLTCovid-19 Multi-Analyte Respiratory Panel Nucleic Acid DevicesNProduct Code
- QLWCovid-19 Test Home Collection Kit DevicesNProduct Code
- QMNCovid-19 Multi-Analyte Antigen DeviceNProduct Code
- QSHCoronavirus Marker DetectionNProduct Code
- QSNOrthopedic Infection Microbial Multiplex Nucleic Acid Detection System2Product Code
- QSSHiv Self-Tests3Product Code
- QTANgs Whole Genome Sequencing For Sars-Cov-2 Genetic AnalysisNProduct Code
- QTPReagents, Monkeypox Virus Nucleic Acid.NProduct Code
- QTQReagents, Non-Variola Orthopoxvirus Nucleic Acid.NProduct Code
- QWBOver-The-Counter Molecular Test To Detect Sars-Cov-2 From Clinical Specimens2Product Code
- QVRMultiplex Nucleic Acid Detection System For Biothreat Agents2Product Code
- QUUSimple In Vitro Diagnostic Device For The Detection Of Secreted Proteins From Bacillus Spp. In Human Clinical Samples2Product Code
- QVFSimple Point-Of-Care Device To Directly Detect Sars-Cov-2 Viral Targets From Clinical Specimens In Near-Patient Settings2Product Code
- QVPSars-Cov-2 Serology Test2Product Code
- QWRSimple Point-Of-Care Device To Detect Sar-Cov-2 Nucleic Acid Targets From Clinical Specimens In Near-Patient Settings2Product Code
- QXALateral Flow Immunochromatography Assay For Host Biomarkers Of Respiratory Infection2Product Code
- QYASystem For Detection Of Nucleic Acid From Non-Viral Microorganism(S) Causing Stis Using Specimens Collected At Home2Product Code
- QYTOver-The-Counter Covid-19 Antigen Test2Product Code
- QZXPositive Blood Culture Processor For Inoculum Preparation Used For Antimicrobial Susceptibility Testing2Product Code
- SANAutomated Antimicrobial Susceptibility Test System For Positive Blood Culture Samples2Product Code
- SBPSimple Point-Of-Care Nucleic Acid-Based Hepatitis C Virus Ribonucleic Acid Test2Product Code
- SBTDevice To Detect Microbial Colonization Directly From Clinical Specimens.2Product Code
- SBZTest For Detection Of Antibodies Associated With Syphilis Performed By Lay Users2Product Code
- SCAMulti-Analyte Respiratory Virus Antigen Detection Test2Product Code
- SDMNucleic Acid Test Used For Screening Of Cadaveric (Non-Heart-Beating) Donors Of Blood Or Blood Products Or Hct/PsUProduct Code
- SDNSerology Test Used For Screening Of Cadaveric (Non-Heart-Beating) Donors Of Blood Or Blood Products Or Hct/PsUProduct Code
- Submissions with No Product CodeMiscellaneous
- Subpart B—Biological StainsCFR Sub-Part
- Subpart B—Clinical Chemistry Test SystemsCFR Sub-Part
- Subpart B—Diagnostic DevicesCFR Sub-Part
- Subpart C—Clinical Laboratory InstrumentsCFR Sub-Part
- Subpart C—Microbiology DevicesCFR Sub-Part
- Subpart D—Serological ReagentsCFR Sub-Part
- Subpart F—Immunological Test SystemsCFR Sub-Part
- NeurologyReview Panel
- Obstetrical and GynecologicalReview Panel
- OphthalmicReview Panel
- OrthopedicReview Panel
- PathologyReview Panel
- Physical MedicineReview Panel
- RadiologyReview Panel
- General and Plastic SurgeryReview Panel
- ToxicologyReview Panel
- Medical GeneticsReview Panel
- UnknownReview Panel
Atellica IM Anti-Hepatitis B core Total (HBcT) Assay
- Page Type
- PMA Approval
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
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