58 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: FDA Class 3
×
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
·MONOLISA ANTI-HBC IGM EIA
Kit, Test, Alpha-Fetoprotein For Neural Tube Defects
FDA Pre-Market Approval
FDA Class 3
·ABBOTT AFP-EIA DIAGNOSTIC KIT
Assay,Enzyme Linked Immunosorbent,Parvovirus B19 Igm
FDA Pre-Market Approval
FDA Class 3
·BIOTRIN PARVOVIRUS IGM EIA (V619IMUS)
Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled
FDA Pre-Market Approval
FDA Class 3
·Natrelle Silicone-Filled Breast Implants
System, Test, Tumor Marker, For Detection Of Bladder Cancer
FDA Pre-Market Approval
FDA Class 3
·NMP22 BladderChek Test
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
Coronary Drug-Eluting Stent
FDA Pre-Market Approval
FDA Class 3
·Resolute Onyx Zotarolimus-Eluting Coronary Stent System
Coronary Drug-Eluting Stent
FDA Pre-Market Approval
FDA Class 3
·Resolute Integrity
Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)
FDA Pre-Market Approval
FDA Class 3
·BIO-RAD MONOLISA ANTI-HBS EIA
Enzyme Immunoassay, Fetal Fibronectin
FDA Pre-Market Approval
FDA Class 3
·FETAL FIBRONECTIN ENZYME IMMUNOASSAY KIT (EIK)
Kit, Assay, Estrogen Receptor
FDA Pre-Market Approval
FDA Class 3
·ABBOTT ER-EIA MONOCLONAL DIAG. KIT
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 MONOLOSA 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 -HBS 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
Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)
FDA Pre-Market Approval
FDA Class 3
·ABBOTT HBE (RDNA) EIA TEST KIT
Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)
FDA Pre-Market Approval
FDA Class 3
·BIO-RAD MONOLISA ANTI-HBS EIA
Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)
FDA Pre-Market Approval
FDA Class 3
·BIO-RAD MONOLISA ANTI-HBS EIA
Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)
FDA Pre-Market Approval
FDA Class 3
·BIO-RAD MONOLISA ANTI-HBS EIA