2,694 results
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20ms
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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
·ARCHITECT AUSAB ASSAY
Assay,Enzyme Linked Immunosorbent,Parvovirus B19 Igg
FDA Pre-Market Approval
FDA Class 3
·PARVOVIRUS B19 IGG ENZYME IMMUNOASSAY
Kit, Rna Detection, Human Papillomavirus
FDA Pre-Market Approval
FDA Class 3
·APTIMA HPV ASSAY
Hepatitis Viral B Dna Detection
FDA Pre-Market Approval
FDA Class 3
·COBAS AMPLIPREP/COBAS TAQMAN HBV TEST V2.0 AND COBAS TAQMAN HBV TEST
Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)
FDA Pre-Market Approval
FDA Class 3
·ETI-EBK PLUS
Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)
FDA Pre-Market Approval
FDA Class 3
·ELECSYS ANTI-HBC ON MODULAR ANALYTICS E170
Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)
FDA Pre-Market Approval
FDA Class 3
·Alinity i Anti-HBs
Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)
FDA Pre-Market Approval
FDA Class 3
·Elecsys Anti-HBc II
Hepatitis Viral B Dna Detection
FDA Pre-Market Approval
FDA Class 3
·COBAS AmpliPrep/COBAS TaqMan HBV Test, v2.0
Hepatitis Viral B Dna Detection
FDA Pre-Market Approval
FDA Class 3
·Abbott Real Time HBV Amplification Reagent Kit / HBV Control Kit / HBV Calibrator Kit
Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)
FDA Pre-Market Approval
FDA Class 3
·VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBE REAGENT PACK AND CALIBRATOR
Test, Immunity, Cell Mediated, Mycobacterium Tuberculosis
FDA Pre-Market Approval
FDA Class 3
·QUANTIFERON-TB GOLD AND TB GOLD- Test (reference lab pack)
Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)
FDA Pre-Market Approval
FDA Class 3
·ARCHITECT HBsAg Next Qualitative/Next Confirmatory, Alinity i HBsAg Next Qualitative/Next Confirmatory
Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)
FDA Pre-Market Approval
FDA Class 3
·ANTI-HBS
Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)
FDA Pre-Market Approval
FDA Class 3
·CORAB
Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)
FDA Pre-Market Approval
FDA Class 3
·LIAISON® XL MUREX HBc IgM and LIAISON® XL MUREX Control HBc IgM
Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)
FDA Pre-Market Approval
FDA Class 3
·LIAISON XL MUREX Anti-HBe and LIAISON XL MUREX Control Anti-HBe
Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)
FDA Pre-Market Approval
FDA Class 3
·ELECSYS ANTI-HBC IMMUNOASSAY ON MODULAR ANALYSTICS E170
Test, Immunity, Cell Mediated, Mycobacterium Tuberculosis
FDA Pre-Market Approval
FDA Class 3
·LIAISON® QuantiFERON®-TB Gold Plus and LIAISON® XL Control QuantiFERON®-TB Gold Plus
Mycobacterium Tuberculosis, Cell Mediated Immune Response, Enzyme-Linked Immunospot Test
FDA Pre-Market Approval
FDA Class 3
·T-SPOT.TB TEST