110 results
·
63ms
·
Sources: EU EUDAMED, US FDA
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
·BIO-RAD MONOLISA ANTI-HBC IGM EIA
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
Bio-Rad Laboratories GmbH
Importer
🇩🇪 Germany·5 Manufacturers
Bio-Rad Laboratories Ges.m.b.H
Importer
🇦🇹 Austria·5 Manufacturers
CE 641606
Certificate
MDD Annex II (excluding section 4)·Rad Source Technologies Inc.·BSI Group The Netherlands B.V.·1 Basic UDI-DI
Seegene Germany GmbH
Importer
🇩🇪 Germany·5 Manufacturers
Vircell, S.L.
Importer
🇪🇸 Spain·5 Manufacturers
Automated Digital Image Manual Interpretation Microscope
FDA classification
FDA Class 2
·Automated Digital Image Manual Interpretation Microscope
SUNGO Europe B.V.
Authorized representative
🇳🇱 Netherlands·1571 Manufacturers·20390 Devices