1,642 results
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169ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Kit, Test, Alpha-Fetoprotein For Neural Tube Defects
FDA Pre-Market Approval
FDA Class 3
·QUANTITOPE 125I AFP KIT AND CONTROL SERUM
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
Kit, Test, Alpha-Fetoprotein For Neural Tube Defects
FDA Pre-Market Approval
FDA Class 3
·AFP/OB(TM) RIA 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
Kit, Test, Alpha-Fetoprotein For Neural Tube Defects
FDA Pre-Market Approval
FDA Class 3
·QUANTITOPE 125I AFP KIT AND CONTROL SERUM
Kit, Test, Alpha-Fetoprotein For Neural Tube Defects
FDA Pre-Market Approval
FDA Class 3
·QUANTITOPE 125I AFP KIT AND CONTROL SERUM
Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)
FDA Pre-Market Approval
FDA Class 3
·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 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 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
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
ACCESS HUMAN FOLLICLE STIMULATING HORMONE ASSAY
FDA 510(k)
FDA Class 1
·Clinical Chemistry
LIQUICHEK TORCH PLUS IGM CONTROL
FDA 510(k)
FDA Class 1
·Clinical Chemistry
ACCESS PROLACTIN
FDA 510(k)
FDA Class 1
·Clinical Chemistry
Hemoglobin Variants System on Newborn Hemoglobin System with GDM and HbReview Software
FDA 510(k)
FDA Class 2
·Hematology
ACCESS RUBELLA IGG
FDA 510(k)
FDA Class 2
·Microbiology
ACCESS PROLACTIN ASSAY (MODIFICATION)
FDA 510(k)
FDA Class 1
·Clinical Chemistry
ACCESS HYPERSENSITIVE TSH REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER
FDA 510(k)
FDA Class 2
·Clinical Chemistry