2,104 results · 30ms · Sources: EU EUDAMED, US FDA

Hepatitis Delta Serological Reagents

FDA Pre-Market Approval
FDA Class 3 ·ABBOTT ANTI-DELTA EIA

Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

FDA Pre-Market Approval
FDA Class 3 ·ELECSCYS HBSAG IMMUNOASSAY, ELECSYS PRECICONTROL HBSAG, ELECSYS HBSAG CONFIRMATORY TEST

Kit, Dna Detection, Human Papillomavirus

FDA Pre-Market Approval
FDA Class 3 ·Alinity m HR HPV

Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

FDA Pre-Market Approval
FDA Class 3 ·ARCHITECT HBSAG QUALITATIVE/CONFIMATORY

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 ·VITROS IMMUNODIAGNOSTIC PRODUCTS HBEAG REAGENT PACK AND CALIBRATOR

Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

FDA Pre-Market Approval
FDA Class 3 ·ELECSYS HBSAG CONFIRMATORY TEST

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 ·ELECSYS ANTI-HBC IMMUNOASSAY, ELECSYS PRECICONTROL ANTI-HBC FOR USE ON THE ELECSYS 2010 IMMUNOASSAY ANALYZER

Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

FDA Pre-Market Approval
FDA Class 3 ·ELECSYS ANTI-HBS CALCHECK

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 & CALIBRATOR

Hepatitis Viral B Dna Detection

FDA Pre-Market Approval
FDA Class 3 ·Aptima HBV Quant Assay

Assay,Enzyme Linked Immunosorbent,Parvovirus B19 Igg

FDA Pre-Market Approval
FDA Class 3 ·Parvovirus B19 IgG Enzyme Immunoassay (V519IGUS)

Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

FDA Pre-Market Approval
FDA Class 3 ·ETI-MAK-2 PLUS and HBsAg Confirmatory Test Assays

Test, Immunity, Cell Mediated, Mycobacterium Tuberculosis

FDA Pre-Market Approval
FDA Class 3 ·QUANTTFERON-TB GOLD AND TB GOLD-IN-THE-TUBE

Test, Immunity, Cell Mediated, Mycobacterium Tuberculosis

FDA Pre-Market Approval
FDA Class 3 ·LIAISON QuantiFERON-TB Gold Plus, LIAISON XL Control QuantiFERON-TB Gold Plus

Hepatitis Viral B Dna Detection

FDA Pre-Market Approval
FDA Class 3 ·Abbott RealTime HBV

Kit, Dna Detection, Human Papillomavirus

FDA Pre-Market Approval
FDA Class 3 ·COBAS HPV TEST, 240 TESTS; COBAS HPV TEST 960 TESTS

Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

FDA Pre-Market Approval
FDA Class 3 ·BIO-RAD MONOLISA ANTI-HBC EIA

Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

FDA Pre-Market Approval
FDA Class 3 ·ANTI-HBC