15 results · 16ms · Sources: EU EUDAMED, US FDA

Get notified when this changes

We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

Qualitative And Quantitative Hepatitis B Virus Antibody Assays

FDA Pre-Market Approval
FDA Class 2 ·IMMULITE 2000 XPI ANTI-HBC IMG

Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)

FDA Pre-Market Approval
FDA Class 2 ·IMMULITE 2000 Anti HBc IgM

Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)

FDA Pre-Market Approval
FDA Class 2 ·IMMULITE/IMMULITE 1000 & IMMULITE 2000 ANTI-HBC

Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)

FDA Pre-Market Approval
FDA Class 2 ·IMMULITE, IMMULITE 1000 ANTI-HBC AND IMMULITE 2000 ANTI-HBC

Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)

FDA Pre-Market Approval
FDA Class 2 ·IMMULITE/IMMULITE 1000 AND IMMULITE 2000 ANTI-HBC IGM

Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)

FDA Pre-Market Approval
FDA Class 2 ·IMMULITE/IMMULITE 1000 & IMMULITE 2000 ANTI-HBC IGM

Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)

FDA Pre-Market Approval
FDA Class 2 ·ANTI-HBC IGM

Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)

FDA Pre-Market Approval
FDA Class 2 ·IMMULITE 2000 Anti-HBc IgM

Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)

FDA Pre-Market Approval
FDA Class 2 ·IMMULITE/IMMULITE 1000 AND IMMULITE 2000 ANTI-HBC IGM

Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)

FDA Pre-Market Approval
FDA Class 2 ·ANTI-HBCM IMMULITE ASSAY

Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)

FDA Pre-Market Approval
FDA Class 2 ·IMMULITE 2000 Anti-HBcM

Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)

FDA Pre-Market Approval
FDA Class 2 ·IMMULITE® 2000 Anti-HBc IgM

Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)

FDA Pre-Market Approval
FDA Class 2 ·ANTI-HBCM IMMULITE SUBSTRATE REAGENT

Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)

FDA Pre-Market Approval
FDA Class 2 ·IMMULITE 2000/2000 XPi Anti-HBc IgM

HUMI-FLOW, MODEL 6-850-00/ 01/02

FDA 510(k)
FDA Class 2 ·Obstetrics/Gynecology