2,104 results · 19ms · Sources: EU EUDAMED, US FDA

Kit, Dna Detection, Human Papillomavirus

FDA Pre-Market Approval
FDA Class 3 ·CERVISTA HPV HR COMPONENTS

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

FDA Pre-Market Approval
FDA Class 3 ·ADVIA CENTAUR HBSAG (HBS) ASSAY

Test, Immunity, Cell Mediated, Mycobacterium Tuberculosis

FDA Pre-Market Approval
FDA Class 3 ·QUANTIFERON-TB

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

FDA Pre-Market Approval
FDA Class 3 ·DIASORIN ETI-CORE-IGMK PLUS

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

FDA Pre-Market Approval
FDA Class 3 ·LIAISON XL MUREX Anti-HBc

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 ·VITROS IMMUNODIAGNOSTIC PRODUCTS HBSAG REAGENT PACK AND CALIBRATOR

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

FDA Pre-Market Approval
FDA Class 3 ·AXSYM HBSAG/HBSAG CONFIRMATORY

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

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

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

FDA Pre-Market Approval
FDA Class 3 ·ARCHITECT CORE (LN 6L22)

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

FDA Pre-Market Approval
FDA Class 3 ·LIAISON® XL MUREX Anti-HBc and LIAISON® XL MUREX Control Anti-HBC

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

FDA Pre-Market Approval
FDA Class 3 ·ARCHITECT HBSAG QUALITATIVE AND ARCHITECT HBSAG QUALITATIVE CONFIRMATORY

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

FDA Pre-Market Approval
FDA Class 3 ·IMMULITE/IMMULITE 1000 AND IMMULITE 2000 ANTI-HBC IGM

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

FDA Pre-Market Approval
FDA Class 3 ·IMMULITE/IMMULITE 1000 & IMMULITE 2000 HBSAG & 2000 HBSAG CONFIRMATORY

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

FDA Pre-Market Approval
FDA Class 3 ·ARCHITECT AUSAB

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 ·COBAS AMPLIPREP/COBAS TAQMAN HBV TEST V2.0,COBAS AMPLIPREP/COBAS TAQMAN WASH REAGENT

Kit, Rna Detection, Human Papillomavirus

FDA Pre-Market Approval
FDA Class 3 ·Aptima HPV 16 18/45 Genotype Assay

Assay,Enzyme Linked Immunosorbent,Parvovirus B19 Igg

FDA Pre-Market Approval
FDA Class 3 ·LIAISON Biotrin Parvovirus B19 IgG Plus, LIAISON Biotrin Control Parvovirus B19 IgG Plus

Mycobacterium Tuberculosis, Cell Mediated Immune Response, Enzyme-Linked Immunospot Test

FDA Pre-Market Approval
FDA Class 3 ·T SPOT-TB TEST