15 results
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16ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: FDA Class 2
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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