2,057 results · 19ms · Sources: EU EUDAMED, US FDA

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

FDA Pre-Market Approval
FDA Class 3 ·LIAISON XL MUREX HBsAg Qual; LIAISON XL MUREX Control HBsAg Qual; LIAISON XL MUREX HBsAg Confirmatory

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

FDA Pre-Market Approval
FDA Class 3 ·Elecsys Anti-HBs II

Test, Immunity, Cell Mediated, Mycobacterium Tuberculosis

FDA Pre-Market Approval
FDA Class 3 ·QUANTIFERON - TB GOLD-IN-TUBE

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

FDA Pre-Market Approval
FDA Class 3 ·ARCHITECT HBSAG & ARCHITECT HBSAG CONFIRMATORY ASSAYS

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

FDA Pre-Market Approval
FDA Class 3 ·ETI-AB-AUK PLUS ASSAY

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

FDA Pre-Market Approval
FDA Class 3 ·ADVIA CENTAUR ANTI-HBS2 ASSAY

Test, Urea Adult And Pediatric (Breath),

FDA Pre-Market Approval
FDA Class 3 ·BREATH TEK UBT FOR H.PYLORI KIT (BREATH TEK UBT KIT) AND PEDIATRIC UREA HYDROLYSIS RATE CALCULATION APPLICATION (PUHR-CA

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

FDA Pre-Market Approval
FDA Class 3 ·DIASORIN ETI-EBK PLUS

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

FDA Pre-Market Approval
FDA Class 3 ·DIASORIN ETI-MAK-2-PLUS

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

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

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

FDA Pre-Market Approval
FDA Class 3 ·ADVIA CENTAUR HBSAGII (HBSII);ADVIA CENTAUR XP HBSAG CONFIRMATORY

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

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

FDA Pre-Market Approval
FDA Class 3 ·Atellica IM Hepatitis B e Antigen (HBeAg)

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 ·AXSYM CORE 2.0

Kit, Dna Detection, Human Papillomavirus

FDA Pre-Market Approval
FDA Class 3 ·COBAS HPV TEST

Hepatitis Viral B Dna Detection

FDA Pre-Market Approval
FDA Class 3 ·COBAS HBV TEST

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

FDA Pre-Market Approval
FDA Class 3 ·ETI-AB-EBK PLUS ASSAY

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

FDA Pre-Market Approval
FDA Class 3 ·ARCHITECT HBSAG QUALITTATIVE/CONFIRMATORY

Kit, Dna Detection, Human Papillomavirus

FDA Pre-Market Approval
FDA Class 3 ·Cervista HPV 16/18 Assay