2,134 results
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18ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: FDA Class 3
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Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)
FDA Pre-Market Approval
FDA Class 3
·ELECSYS HBSAG IMMUNOASSAY
Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)
FDA Pre-Market Approval
FDA Class 3
·ARCHITECT HBsAg Next Qualitative and ARCHITECT HBsAg Next Confirmatory Assay
Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)
FDA Pre-Market Approval
FDA Class 3
·ABBOTT AXSYM AUSAB
Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)
FDA Pre-Market Approval
FDA Class 3
·Elecsys HBsAg II Auto Confirm
Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)
FDA Pre-Market Approval
FDA Class 3
·LIAISON® XL MUREX Anti-HBs, LIAISON® XL MUREX Control Anti-HBs and LIAISON® XL MUREX Anti-HBs Verifiers
Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)
FDA Pre-Market Approval
FDA Class 3
·VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC REAGENT PACK AND CALIBRATOR
Test, Immunity, Cell Mediated, Mycobacterium Tuberculosis
FDA Pre-Market Approval
FDA Class 3
·QUANTTFERON-TB Gold
Kit, Dna Detection, Human Papillomavirus
FDA Pre-Market Approval
FDA Class 3
·VIRAPAP HUMAN PAPILLOMAVIRUS DNA DETECTION KIT
Kit, Dna Detection, Human Papillomavirus
FDA Pre-Market Approval
FDA Class 3
·BD Onclarity HPV Assay
Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)
FDA Pre-Market Approval
FDA Class 3
·VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC IGM REAGENT PACK AND CALIBRATOR
Kit, Dna Detection, Human Papillomavirus
FDA Pre-Market Approval
FDA Class 3
·HC2 High-Risk HPV DNA Test and digene / HC2 HPV DNA Test
Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)
FDA Pre-Market Approval
FDA Class 3
·ARCHITECT CORE-M
Kit, Dna Detection, Human Papillomavirus
FDA Pre-Market Approval
FDA Class 3
·Cervista HPV 16/18 Assay
Kit, Rna Detection, Human Papillomavirus
FDA Pre-Market Approval
FDA Class 3
·Aptima HPV Assay
Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)
FDA Pre-Market Approval
FDA Class 3
·ADVIA Centaur® and Atellica IM Hepatitis B Core IgM (AHBcM) Assay
Hepatitis Viral B Dna Detection
FDA Pre-Market Approval
FDA Class 3
·Alinity m HBV Assay
Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)
FDA Pre-Market Approval
FDA Class 3
·ARCHITECT CORE-M
Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)
FDA Pre-Market Approval
FDA Class 3
·ANTI-HBC IMMULITE SUBSTRATE REAGENT
Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)
FDA Pre-Market Approval
FDA Class 3
·ARCHITECT HBSAG/CONFIRMATORY
Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)
FDA Pre-Market Approval
FDA Class 3
·ELECSYS HBSAG IMMUNOASSAY, ELECSYS HBSAG CONFIRMATORY TEST AND ELECSYS PRECICONTROL HBSAG