1,349 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: FDA Class 3
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Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)
FDA Pre-Market Approval
FDA Class 3
·AXSYM HBSAG
Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)
FDA Pre-Market Approval
FDA Class 3
·ARCHITECT CORE
Sealant, Polymerizing
FDA Pre-Market Approval
FDA Class 3
·COSEAL SURGICAL SEALANT
Hepatitis Viral B Dna Detection
FDA Pre-Market Approval
FDA Class 3
·ABBOTT REALTIME HBV
Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)
FDA Pre-Market Approval
FDA Class 3
·ARCHITECT AUSAB
Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)
FDA Pre-Market Approval
FDA Class 3
·ARCHITECT CORE / Alinity i Anti-HBc
Hepatitis Viral B Dna Detection
FDA Pre-Market Approval
FDA Class 3
·Abbott RealTime HBV Assay
Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)
FDA Pre-Market Approval
FDA Class 3
·ARCHITECT CORE
Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)
FDA Pre-Market Approval
FDA Class 3
·ARCHITECT HBsAg Qualitative Confirmatory/ Alinity i HBsAg Qualitative II Confirmatory
System, Test, Her-2/Neu, Nucleic Acid Or Serum
FDA Pre-Market Approval
FDA Class 3
·PATHVYSION HER-2 DNA PROBE KIT
Absorbable Collagen Hemostatic Agent With Thrombin
FDA Pre-Market Approval
FDA Class 3
·Floseal Hemostatic Matrix (FLOSEAL)
Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)
FDA Pre-Market Approval
FDA Class 3
·ARCHITECT AUSAB; Alinity i Anti-HBs
Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)
FDA Pre-Market Approval
FDA Class 3
·Alinity i HBsAg Next Qualitative assay, Alinity i HBsAg Next Confirmatory assay
Sealant, Polymerizing
FDA Pre-Market Approval
FDA Class 3
·COSEAL SURGICAL SEALANT
Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)
FDA Pre-Market Approval
FDA Class 3
·CORAB
Total, Prostate Specific Antigen (Noncomplexed & Complexed) For Detection Of Prostate Cancer
FDA Pre-Market Approval
FDA Class 3
·AXSYM TOTAL PSA & ARCHITECT TOTAL PSA
Barrier, Absorbable, Adhesion
FDA Pre-Market Approval
FDA Class 3
·SEPRAFILM ADHESION BARRIER/SEPRAFILM PROCEDURE PACK
Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)
FDA Pre-Market Approval
FDA Class 3
·AXSYM CORE 2.0
Kit, Assay, Progesterone Receptor
FDA Pre-Market Approval
FDA Class 3
·ABBOTT PGR-EIA MONOCLONAL
Total, Prostate Specific Antigen (Noncomplexed & Complexed) For Detection Of Prostate Cancer
FDA Pre-Market Approval
FDA Class 3
·ARCHITECT TOTAL PSA