2,694 results
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23ms
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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
·VITROS IMMUNODIAGNOSTIC PRODUCTS HBSAG REAGENT PACK & CALIBRATOR, HBSAG CONFIRMATORY ASSAY
Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)
FDA Pre-Market Approval
FDA Class 3
·ETI-CORE-IGMK PLUS
Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)
FDA Pre-Market Approval
FDA Class 3
·ETI-EBK PLUS assay
Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)
FDA Pre-Market Approval
FDA Class 3
·ADVIA Centaur HBsAg
Hepatitis Viral B Dna Detection
FDA Pre-Market Approval
FDA Class 3
·Abbott RealTime HBV Assay
Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)
FDA Pre-Market Approval
FDA Class 3
·HBSAG IMMULITE SUBSTRATE REAGENT
Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)
FDA Pre-Market Approval
FDA Class 3
·ARCHITECT AUSAB
Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)
FDA Pre-Market Approval
FDA Class 3
·ELECSYS ANTI-HBS CALCHECK
Kit, Dna Detection, Human Papillomavirus
FDA Pre-Market Approval
FDA Class 3
·CERVISTA HPV HR
Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)
FDA Pre-Market Approval
FDA Class 3
·ETI-AB-AUK-PLUS
Kit, Dna Detection, Human Papillomavirus
FDA Pre-Market Approval
FDA Class 3
·BD Onclarity HPV Assay
Kit, Dna Detection, Human Papillomavirus
FDA Pre-Market Approval
FDA Class 3
·COBAS HPV TEST
Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)
FDA Pre-Market Approval
FDA Class 3
·ARCHITECT HBSAG/CONFIRMATORY
Test, Immunity, Cell Mediated, Mycobacterium Tuberculosis
FDA Pre-Market Approval
FDA Class 3
·LIAISON® QuantiFERON TB-Gold Plus assay and Control
Mycobacterium Tuberculosis, Cell Mediated Immune Response, Enzyme-Linked Immunospot Test
FDA Pre-Market Approval
FDA Class 3
·T-SPOT.TB Test
Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)
FDA Pre-Market Approval
FDA Class 3
·LIAISON® XL MUREX HBsAg Qual assay and Control
Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)
FDA Pre-Market Approval
FDA Class 3
·ETI-MAK-2 PLUS, HBsAg Confirmatory Test Assays
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
Hepatitis Viral B Dna Detection
FDA Pre-Market Approval
FDA Class 3
·COBAS AmpliPrep/COBAS TaqMan HBV Test, V2.0
Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)
FDA Pre-Market Approval
FDA Class 3
·ETI-AB-EBK PLUS ASSAY