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
- 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
- K221693Elecsys Anti-HCV II (08837031190)3Cleared 510(K)
- P190011LIAISON XL MUREX HCV Ab; LIAISON XL MUREX Control HCV AbAPPRPMA Approval
- P140021ELECSYS ANTI-HCV II IMMUNOASSAY, ELECSYS PRECICONTROL ANTI-HCVAPPRPMA Approval
- P080027ORAQUICK HCV RAPID ANTIBODY TESTAPPRPMA Approval
- P090009ELECSYS ANTI-HCV IMMUNOASSAY & ELECSYS PRECICONTROL ANTI-HCV FOR USE ON MODULAR ANALYTICS E170 IMMUNOSSAY ANALYZERAPPRPMA Approval
- P090007ELECSYS ANTI-HCV IMMUNOASSAY, ELECSYS PRECICONTROL ANTI-HCV FOR USE ON COBAS E411 IMMUNOSSAY ANALYZERAPPRPMA Approval
- P090008ELECSYS ANTI-HCV IMMUNOASSAY & ELECSYS PRECICONTROL ANTI-HCV FOR USE ON COBAS E601 IMMUNOSSAY ANALYZERAPPRPMA Approval
- P050042ARCHITECT ANTI-HCV ASSAY; ARCHITECT ANTI-HCV CALIBRATOR; ARCHITECT ANTI-HCV CONTROLAPPRPMA Approval
- P030056ADVIA CENTAUR HCV READY PACK REAGENTS, ADVIA CENTAUR HCV QUALITY CONTROL MATERIALSAPPRPMA Approval
- P970027ABBOTT AXSYM ANTIBODY TO HCVAPWDPMA Approval
- P050042ARCHITECT Anti-HCV, Alinity i Anti-HCV3PMA Approval
- P030056ADVIA CENTAUR HCV ReadyPack Reagents and Quality Control Materials3PMA Approval
- P010021VITROS Immunodiagnostic Products Anti-HCV Reagent Pack and Calibrator3PMA Approval
- P190011LIAISON XL MUREX HCV Ab3PMA Approval
- P030056ADVIA Centaur HCV, and Atellica HCV3PMA Approval
- P050042Alinity i Anti-HCV Reagent Kit3PMA Approval
- P050042Alinity i Anti-HCV3PMA Approval
- P050042ARCHITECT Anti-HCV3PMA Approval
- P050042ARCHITECT Anti-HCV and Alinity i Anti-HCV3PMA Approval
- P190011LIAISON XL MUREX HCV Ab3PMA Approval
- P030056Atellica IM Hepatitis C (aHCV) Assay3PMA Approval
- P030056ADVIA Centaur and Atellica IM HCV3PMA Approval
- P190011LIAISON XL MUREX HCV Ab; LIAISON XL MUREX Control HCV Ab3PMA Approval
- P080027OraQuick HCV Rapid Antibody Test3PMA Approval
- P050042Architect Anti-HCV and Alinity i Anti-HCV3PMA Approval
- P010021VITROS Immunodiagnostic Products Anti-HCV Reagent Pack and Calibrator3PMA Approval
- P050042Alinity i Anti-HCV Reagent Kit, Alinity i Anti-HCV Calibrator, Alinity i Anti-HCV Controls3PMA Approval
- P090009Elecsys Anti-HCV Immunoassay3PMA Approval
- P090007Elecsys Anti-HCV Immunoassay3PMA Approval
- P140021Elecsys Anti-HCV II3PMA Approval
- P090008Elecsys Anti-HCV Immunoassay3PMA Approval
- P030056Atellica IM Hepatitis C (aHCV) Assay3PMA Approval
- P050042ARCHITECT Anti-HCV Reagent Kit3PMA Approval
- P010021VITROS Immunodiagnostic Products Anti-HCV Reagent Pack and Calibrator3PMA Approval
- P080027OraQuick HCV Rapid Antibody Test3PMA Approval
- P050042ARCHITECT Anti-HCV (LN 1L79)3PMA Approval
- P050042Architect Anti-HCV Regent Kit (100, 500 Test)3PMA Approval
- P140021Elecsys ANti-HCV II (100/200 tests)3PMA Approval
- P050042ARCHITECT Anti-HCV3PMA Approval
- P030056Atellica IM Analyzer Hepatitis C (aHCV)3PMA Approval
- P010021VITROS Immunodiagnostic Products Anti-HCV Reagent Pack and Calibrator3PMA Approval
- P010021VITROS Immunodiagnostic Products Anti-HCV Reagent Pack and Calibrator3PMA Approval
- P140021Elecsys Anti-HCV II3PMA Approval
- P090008Elecsys Anti-HCV Immunoassay3PMA Approval
- P030056Atellica IM Hepatitis C (aHCV)3PMA Approval
- P140021Elecsys Anti-HCV II3PMA Approval
- P090007Elecsys Anbti-HCV Immunoassay3PMA Approval
- P080027OraQuick HCV Rapid Antibody Test3PMA Approval
- P080027OraQuick HCV Rapid Antibody Test3PMA Approval
- P080027OraQuick HCV Rapid Antibody Test3PMA Approval
- P090009Elecsys Anti-HCV Immunoassay3PMA Approval
- P090008Elecsys Anti-HCV Immunoassay3PMA Approval
- P140021Elecsys Anti-HCV II3PMA Approval
- P090007Elecsys Anti-HCV Immunoassay3PMA Approval
- P140021Elecsys Anti-HCV II, PreciControl Anti-HCV3PMA Approval
- P080027OraQuick HCV Rapid Antibody Test3PMA Approval
- P080027OraQuick HCV Rapid Antibody Test3PMA Approval
- P140021Elecsys Anit-HCV II3PMA Approval
- P090008Elecsys Anit-HCV3PMA Approval
- P090009Elecsys Anit-HCV3PMA Approval
- P090007Elecsys Anit-HCV3PMA Approval
- P140021Elecsys Anti-HCV II Test System3PMA Approval
- P080027OraQuick HCV Antibody Test3PMA Approval
- P140021Elecsys Anti-HCV II (100/200 tests) Immunoassay3PMA Approval
- P080027OraQuick HCV Rapid Antibody Test3PMA Approval
- P080027ORAQUICK HCV RAPID ANTIBODY TEST3PMA Approval
- P080027OraQuick HCV Rapid Antibody Test3PMA Approval
- P010021VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HCV REAGENT PACK AND CALIBRATOR3PMA Approval
- P080027ORAQUICK HCV RAPID ANTIBODY TEST3PMA Approval
- P140021ELECSYS ANTI-HCV II IMMUNOASSAY.3PMA Approval
- P030056ADVIA Centaur® HCV assay3PMA Approval
- P140021ELECSYS ANTI-HCV II IMMUNOASSAY3PMA Approval
- P140021ELECSYS ANTI-HCV II TEST SYSTEM3PMA Approval
- P080027ORAQUICK HCV RAPID ANTIBODY TEST3PMA Approval
- P140021ELECSYS ANTI-HCV II IMMUNOASSAY3PMA Approval
- P050042ARCHITECT ANTI-HCV ASSAY; ARCHITECT ANTI-HCV CALIBRATOR; ARCHITECT ANTI-HCV CONTROL3PMA Approval
- P090008ELECSYS ANTI-HCV IMMUNOASSAY & ELECSYS PRECICONTROL ANTI-HCV FOR USE ON COBAS E601 IMMUNOSSAY ANALYZER3PMA Approval
- P090009ELECSYS ANTI-HCV IMMUNOASSAY & ELECSYS PRECICONTROL ANTI-HCV FOR USE ON MODULAR ANALYTICS E170 IMMUNOSSAY ANALYZER3PMA Approval
- P140021ELECSYS ANTI-HCV II IMMUNOASSAY, ELECSYS PRECICONTROL ANTI-HCV3PMA Approval
- P090007ELECSYS ANTI-HCV IMMUNOASSAY, ELECSYS PRECICONTROL ANTI-HCV FOR USE ON COBAS E411 IMMUNOSSAY ANALYZER3PMA Approval
- P090007ELECSYS ANTI-HCV TEST SYSTEM3PMA Approval
- P140021ELECSYS ANTI-HCV II TEST SYSTEM3PMA Approval
- P090008ELECSYS ANTI-HCV TEST SYSTEM3PMA Approval
- P090009ELECSYS ANTI-HCV TEST SYSTEM3PMA Approval
- P080027ORAQUICK HCV RAPID ANTIBODY TEST3PMA Approval
- P980046HOME ACCESS HEPATITIS C CHECK3PMA Approval
- P090008ELECSYS ANTI-HCV3PMA Approval
- P140021ELECSYS ANTI-HCV II3PMA Approval
- P090009ELECSYS ANTI-HCV3PMA Approval
- P090007ELECSYS ANTI-HCV3PMA Approval
- P080027ORAQUICK HCV RAPID ANTIBODY TEST3PMA Approval
- P010021VITROS ANTI-HCV ASSAY3PMA Approval
- P050042ARCHITECT ANTI-HCV (LN 1L79)3PMA Approval
- P010021VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HCV REAGENT PACK AND CALIBRATOR3PMA Approval
- P030056ADVIA CENTAUR HCV ASSAY3PMA Approval
- P140021ELECSYS ANTI-HCV II IMMUNOASSAY, ELECSYS PRECICONTROL ANTI-HCV3PMA Approval
- P010021VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HCV REAGENT PACK & VITRO IMMUNODIAGNOSTIC PRODUCTS ANTI-HCV CALIBRATOR3PMA Approval
- P030056ADVIA CENTAUR HCV READYPACKS3PMA Approval
- P080027ORAQUICK HCV RAPID ANTIBODY TEST3PMA Approval
- P050042ARCHITECT ANTI-HCV3PMA Approval
- P050042ARCHITECT ANTI-HCV (LN IL79)3PMA Approval
- P080027ORAQUICK HCV RAPID ANTIBODY TEST3PMA Approval
- P090008ELECSYS ANTI-HCV IMMUNOASSAY ON COBAS E 601 AND COBAS E 6023PMA Approval
- P090007ELECSYS ANTI-HCV IMMUNOASSAY ON COBAS E 4113PMA Approval
- P090009ELECSYS ANTI-HCV IMMUNOASSAY ON MODULAR ANALYTICS E 1703PMA Approval
- P080027ORAQUICK HCV RAPID ANTIBODY TEST3PMA Approval
- P080027ORAQUICK HCV RAPID ANTIBODY TEST3PMA Approval
- P090008ELECSYS ANTI-HCV3PMA Approval
- P050042ARCHITECT ANTI-HCV3PMA Approval
- P080027ORAQUICK HCV RAPID ANTIBODY TEST3PMA Approval
- P050042ARCHITECT ANTI-HCV3PMA Approval
- P050042ARCHITECT ANTI-HCV3PMA Approval
- P050042ARCHITECT ANTI-HCV ASSAY, LN IL793PMA Approval
- P080027ORAQUICK HCV RAPID ANTIBODY TEST3PMA Approval
- P080027ORAQUICK HCV RAPID ANTIBODY TEST3PMA Approval
- P050042ARCHITECT ANTI-HCV LN 1L793PMA Approval
- P080027ORAQUICK HCV RAPID ANTIBODY TEST3PMA Approval
- P080027ORAQUICK HCV RAPID ANTIBODY TEST3PMA Approval
- P050042ARCHITECT ANTI-HCV3PMA Approval
- P080027ORAQUICK HCV RAPID ANTIBODY TEST3PMA Approval
- P080027ORAQUICK HCV RAPID ANTIBODY TEST3PMA Approval
- P050042ARCHITECT ANTI-HCV3PMA Approval
- P050042ARCHITECT ANTI-HCV3PMA Approval
- P010021VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HCV REAGENT PACK3PMA Approval
- P080027ORAQUICK HCV RAPID ANTIBODY TEST3PMA Approval
- P090009ELECSYS ANTI-HCV IMMUNOASSAY (MODULAR ANALYTICS E170) AND PRECICONTROL ANTI-HCV3PMA Approval
- P090008ELECSYS ANTI-HCV IMMUNOASSAY (COBAS E 601) AND PRECICONTROL ANTI-HCV3PMA Approval
- P090007ELECSYS ANTI-HCV IMMUNOASSAY (COBAS E 411) AND PRECICONTROL ANTI-HCV3PMA Approval
- P090007ELECSYS ANTI-HCV ON COBAS E 4113PMA Approval
- P090008ELECSYS ANTI-HCV ON COBAS E 6013PMA Approval
- P090009ELECSYS ANTI-HCV ON MODULAR ANALYTICS E1703PMA Approval
- P080027ORAQUICK HCV RAPID ANTIBODY TEST3PMA Approval
- P050042ARCHITECT ANTI-HCV3PMA Approval
- P050042ARCHITECT ANTI-HCV3PMA Approval
- P050042ARCHITECT ANTI-HCV3PMA Approval
- P970027AXSYM ANTI-HCV3PMA Approval
- P010021VITROS ANTI-HCV3PMA Approval
- P030056ADVIA CENTAUR HCV ASSAY3PMA Approval
- P090007ELECSYS ANTI-HCV IMMUNOASSAY ON CABAS E 4113PMA Approval
- P090008ELECSYS ANTI-HCV IMMUNOASSAY ON COBAS E 6013PMA Approval
- P090009ELECSYS ANTI-HCV IMMUNOASSAY ON MODULAR ANALYTICS E1703PMA Approval
- P050042ARCHITECT ANTI-HCV3PMA Approval
- P050042ARCHITECT ANTI-HCV3PMA Approval
- P090008ELECSYS ANTI-HCV IMMUNOASSAY3PMA Approval
- P050042ARCHTECT ANTI-HCV3PMA Approval
- P090007ELECSYS ANTI-HCV ON COBAS E 4113PMA Approval
- P090009ELECSYS ANTI-HCV ON MODULAR ANALYTICS E1703PMA Approval
- P090008ELECSYS ANTI-HCV ON COBAS E 6013PMA Approval
- P010021VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HCV REAGENT PACK AND CALIBRATOR3PMA Approval
- P970027AXSYM ANTI-HCV (LN 5C36)3PMA Approval
- P050042ACHITECT ANTI-HCV3PMA Approval
- P090008ELECSYS ANTI-HCV IMMUNOASSAY COBAS E 6013PMA Approval
- P090007ELECSYS ANTI-HCV INMMUNOASSAY ON COBAS E 4113PMA Approval
- P090009ELECSYS ANTI-HCV IMMUNOASSAY ON MUDULAR ANALYTICS3PMA Approval
- P050042ARCHITECT ANTI-HCV3PMA Approval
- P090007ELECSYS ANTI-HCV IMMUNOASSAY ON COBAS E 4113PMA Approval
- P090009ELECSYS ANTI-HCV IMMUNOASSAY ON MODULAR ANALYTICS E1703PMA Approval
- P090008ELECSYS ANTI-HCV IMMUNOASSAY ON COBAS E 6013PMA Approval
- P090007ELECSYS ANTI-HCV IMMUNOASSAY ON COBAS E 4113PMA Approval
- P090009ELECSYS ANTI-HCV IMMUNOASSAY ON MODULAR ANALYSTICS E1703PMA Approval
- P090008ELECSYS ANTI -HCV IMMUNOASSAY ON COBAS E 6013PMA Approval
- P010021VITROS INMMUNODIAGNOSTIC PRODUCTS ANTI-HCV ASSAY3PMA Approval
- P080027ORAQUICK RAPID HCV ANTIBODY3PMA Approval
- P970027AXSYM ANTI-HCV3PMA Approval
- P970027AXSYM ANTI-HCV3PMA Approval
- P090008ELECSYS ANTI-HCV IMMUNOASSAY & ELECSYS PRECICONTROL ANTI-HCV FOR USE ON COBAS E6013PMA Approval
- P090009ELECSYS ANTI-HCV IMMUNOASSAY & ELECSYS PRECICONTROL ANTI-HCV FOR USE ON E170 IMMUNOASSAY ANALYZER3PMA Approval
- P090007ELECSYS ANTI-HCV IMMUNOASSAY & ELECSYS PRECICONTROL ANTI-HCV FOR USE ON COBAS E4113PMA Approval
- P010021VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HCV REAGENT PACK AND CALIBRATOR3PMA Approval
- P980046HOME ACCESS HEPATITIS C CHECK TEST SYSTEM3PMA Approval
- P010021VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HCV REAGENT PACK & CALIBRATOR3PMA Approval
- P080027ORAQUICK HCV RAPID ANTIBODY TEST3PMA Approval
- P050042ARCHITECT ANTI-HCV3PMA Approval
- P050042ARCHITECT ANTI-HCV3PMA Approval
- P970027AXSYM ANTI-HCV3PMA Approval
- P050042ARCHITECT ANTI-HCV3PMA Approval
- P970027AXSYM ANTI-HCV3PMA Approval
- P050042ARCHITECT ANTI-HCV3PMA Approval
- P090008ELECSYS ANTI-HCV IMMUNOASSAY3PMA Approval
- P090009ELECSYS ANTI-HCV IMMUNOASSAY3PMA Approval
- P090007ELECSYS ANTI-HCV IMMUNOASSAY3PMA Approval
- P080027ORAQUICK HCV RAPID ANTIBODY TEST3PMA Approval
- P970027AXSYM ANTI-HCV3PMA Approval
- P050042ARCHITECT ANTI-HCV3PMA Approval
- P080027ORAQUICK HCV RAPID ANTIBODY TEST3PMA Approval
- P050042ARCHITECT ANTI-HCV3PMA Approval
- P050042ARCHITECT ANTI-HCV3PMA Approval
- P970027AXSYM ANTI-HCV3PMA Approval
- P050042ABBOTT ARCHITECT ANTI-HCV3PMA Approval
- P970027AXSYM ANTI-HCV (LN 5C36)3PMA Approval
- P090007ELECSYS ANTI-HCV IMMUNOASSAY & ELECSYS PRECICONTROL ANTI-HCV FOR USE ON THE ROCHE COBAS E 411 IMMUNOASSAY ANALYZER3PMA Approval
- P090009ELECSYS ANTI-HCV IMMUNOASSAY & ELECSYS PRECICONTROL ANTI-HCV FOR USE ON THE MODULAR ANALYTICS E170 IMMUNOASSAY ANALYZER3PMA Approval
- P090008ELECSYS ANTI-HCV IMMUNOASSAY & ELECSYS PRECICONTROL ANTI-HCV FOR USE ON THE ROCHE COBAS E 601 IMMUNOASSAY ANALYZER3PMA Approval
- P970027AXSYM ANTI-HCV3PMA Approval
- P010021ANTI-HCV REAGENT PACK AND CALIBRATOR3PMA Approval
- P080027ORAQUICK HCV RAPID ANTIBODY TEST3PMA Approval
- P010021VITROS IMMUNODIAGNOSTIC PRODUCT ANTI-HCV REAGENT PACK & CALIBRATOR3PMA Approval
- P970027ABBOTT AXSYM ANTI-HCV3PMA Approval
- P090009ELECSYS ANTI-HCV IMMUNOASSAY & ELECSYS PRECICONTROL ANTI-HCV FOR USE ON MODULAR ANALYTICS E170 IMMUNOSSAY ANALYZER3PMA Approval
- P090008ELECSYS ANTI-HCV IMMUNOASSAY & ELECSYS PRECICONTROL ANTI-HCV FOR USE ON COBAS E601 IMMUNOSSAY ANALYZER3PMA Approval
- P090007ELECSYS ANTI-HCV IMMUNOASSAY, ELECSYS PRECICONTROL ANTI-HCV FOR USE ON COBAS E411 IMMUNOSSAY ANALYZER3PMA Approval
- P030056ADVIA CENTAUR SOFTWARE V4.0 SP1 ANTI-HCV3PMA Approval
- P030056ADVIA CENTAUR XP SOFTWARE V6.0 ANTI-HCV3PMA Approval
- P030056ADVIA CENTAUR HCV ON CENTAUR CP3PMA Approval
- P010021VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HCV REAGENT PACK AND CALIBRATOR3PMA Approval
- P970027ABBOTT AXSYM ANTIBODY TO HCV (ANTI-HCV)3PMA Approval
- P050042ARCHITECT ANTI-HCV ASSAY/CALIBRATOR/CONTROL3PMA Approval
- P030056ADVIA CENTAUR HCV READYPACK REAGENNTS/QUALITY CONTROL MATERIALS3PMA Approval
- P010021VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HCV REAGENT PACK & CALIBRATORS3PMA Approval
- P030056ADVIA CENTAUR HCV3PMA Approval
- P050042ABBOTT ARCHITECT ANTI-HCV3PMA Approval
- P010021VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HCV REAGENT PACK & CALIBRATOR3PMA Approval
- P010021VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HCV REAGENT PACK AND CALIBRATOR3PMA Approval
- P970027ABBOTT AXSYM ANTI-HCV3PMA Approval
- P010021VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HCV REAGENT PACK & CALIBRATORS3PMA Approval
- P050042ABBOTT ARCHITECT ANTI-HCV3PMA Approval
- P010021VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HCV REAGENT PACK AND VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HCV CALIBRATOR3PMA Approval
- P010021VITROS IMMUNODIAGNOSTIC PRODUCTS HCV REAGENT PACK & CALIBRATOR3PMA Approval
- P050042ARCHITECT ANTI-HCV3PMA Approval
- P970027AXSYM ANTIBODY TO HCV3PMA Approval
- P050042ARCHITECT ANTI-HCV REAGENT KITS, ARCHITECT ANTI-HCV CALIBRATORS, AND ARCHITECT ANTI-HCV CONTROLS3PMA Approval
- P050042ARCHITECT ANTI-HCV ASSAY; ARCHITECT ANTI-HCV CALIBRATOR; ARCHITECT ANTI-HCV CONTROL3PMA Approval
- P010021VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HCV REAGENT PACK AND CALIBRATOR3PMA Approval
- P010021VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HCV REAGENT PACK AND CALIBRATOR3PMA Approval
- P010021VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HCV REAGENT PACK AND CALIBRATOR3PMA Approval
- P010021VITROS IMMUNODIAGNOSTIC ANTI-HCV REAGENT PACK AND CALIBRATOR3PMA Approval
- P970027ABBOTT AXSYM ANTI-HCV (LIST NUMBER 5C36)3PMA Approval
- P030056ADVIA CENTAUR HCV READY PACK REAGENTS, ADVIA CENTAUR HCV QUALITY CONTROL MATERIALS3PMA Approval
- P970027ABBOTT AXSYM ANTI-HCV3PMA Approval
- P980046HEPATITS C CHECK TEST SYSTEM3PMA Approval
- P970027AXSYM ANTI-HCV3PMA Approval
- P010021VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HCV REAGENT PACK & CALIBRATOR3PMA Approval
- P010021VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HCV REAGENT PACK AND CALIBRATOR3PMA Approval
- P010021VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HCV REAGENT PACK AND CALIBRATORS3PMA Approval
- P970027ABBOTT AXSYM ANTI-HCV3PMA Approval
- P970027ABBOTT AXSYM ANTIBODY TO HCV3PMA Approval
- P980046HOME ACCESS HEPATITIS C CHECK TEST SERVICE3PMA Approval
- P010021VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HCV REAGENT PACK & CALIBRATORS3PMA Approval
- P980046HOME ACCESS HEPATITIS C TEST SERVICE3PMA Approval
- P010021VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HCV REAGENT PACK AND CALIBRATOR3PMA Approval
- P980046HOME ACCESS HEPATITIS C CHECK TEST3PMA Approval
- P980046HEPATITIS C CHECK TESTING SERVICE3PMA Approval
- P980046HOME ACCESS HEPATITIS C CHECK AND HEPATITIS C CHECK EXPRESS3PMA Approval
- 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
HOME ACCESS HEPATITIS C CHECK
- Page Type
- PMA Approval
- 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