1,349 results
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22ms
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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
·ARCHITECT HBSAG/CONFIRMATORY
Kit, Test, Alpha-Fetoprotein For Neural Tube Defects
FDA Pre-Market Approval
FDA Class 3
·ABBOTT AFP
Agent, Absorbable Hemostatic, Collagen Based
FDA Pre-Market Approval
FDA Class 3
·FLOSEAL HEMOSTATIC MATRIX
Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)
FDA Pre-Market Approval
FDA Class 3
·ARCHITECT AUSAB and Alinity i Anti-HBs
Kit, Assay, Progesterone Receptor
FDA Pre-Market Approval
FDA Class 3
·PGR-EIA MONOCLONAL
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
Test, Prostate Specific Antigen, Free, (Noncomplexed) To Distinguish Prostate Cancer From Benign Conditions
FDA Pre-Market Approval
FDA Class 3
·ARCHITECT FREE PSA
Hepatitis Viral B Dna Detection
FDA Pre-Market Approval
FDA Class 3
·ABBOTT REALTIME HBV
Implant, Corneal, Refractive
FDA Pre-Market Approval
FDA Class 3
·INTACS PRESCRIPTION INSERTS
Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)
FDA Pre-Market Approval
FDA Class 3
·ARCHITECH CORE
Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)
FDA Pre-Market Approval
FDA Class 3
·ABBOTT AXSYM HBSAG ASSAY
System, Test, Her-2/Neu, Nucleic Acid Or Serum
FDA Pre-Market Approval
FDA Class 3
·PATH VYSION HER-2 DNA PROBE KIT ASSAY
Agent, Absorbable Hemostatic, Collagen Based
FDA Pre-Market Approval
FDA Class 3
·FLOSEAL HEMOSTATIC MATRIX
Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)
FDA Pre-Market Approval
FDA Class 3
·ARCHITECT CORE
Agent, Absorbable Hemostatic, Collagen Based
FDA Pre-Market Approval
FDA Class 3
·FLOSEAL MATRIX/PROCEED HEMOSTATIC SEALANTS
Fluorescence In Situ Hybridization, Anaplastic Lymphoma Kinase, Gene Rearrangement
FDA Pre-Market Approval
FDA Class 3
·Vysis ALK Break Apart Fish Probe Kit
Hepatitis Viral B Dna Detection
FDA Pre-Market Approval
FDA Class 3
·Alinity m HBV
Absorbable Collagen Hemostatic Agent With Thrombin
FDA Pre-Market Approval
FDA Class 3
·Floseal Hemostatic Matrix
Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)
FDA Pre-Market Approval
FDA Class 3
·AXSYM HBSAG/CONFIRMATORY (LN 9B01)
Kit, Test, Alpha-Fetoprotein For Neural Tube Defects
FDA Pre-Market Approval
FDA Class 3
·ARCHITECT AFP (LN 3P36)