1,424 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: FDA Class 3
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Test, Prostate Specific Antigen, Free, (Noncomplexed) To Distinguish Prostate Cancer From Benign Conditions
FDA Pre-Market Approval
FDA Class 3
·ARCHITECT FREE PSA
Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)
FDA Pre-Market Approval
FDA Class 3
·ARCHITECT AUSAB REAGENT KIT, ARCHITECT AUSAB CALIBRATORS, ARCHITECT AUSAB CONTROLS
Test, Prostate Specific Antigen, Free, (Noncomplexed) To Distinguish Prostate Cancer From Benign Conditions
FDA Pre-Market Approval
FDA Class 3
·ARCHITECT FREE PSA
Kit, Test, Alpha-Fetoprotein For Neural Tube Defects
FDA Pre-Market Approval
FDA Class 3
·AXSYM AFP (LN 7A48)
Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)
FDA Pre-Market Approval
FDA Class 3
·CORAB
Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)
FDA Pre-Market Approval
FDA Class 3
·ARCHITECT HBSAG/CONFIRMATORY
Kit, Assay, Progesterone Receptor
FDA Pre-Market Approval
FDA Class 3
·IMMUNOCYTOCHEMICAL ASSAY TO DETECT PROGESTERONE
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
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, Prostate Specific Antigen, Free, (Noncomplexed) To Distinguish Prostate Cancer From Benign Conditions
FDA Pre-Market Approval
FDA Class 3
·ARCHITECT FREE PSA AND AXSYM FREE PSA
Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)
FDA Pre-Market Approval
FDA Class 3
·ARCHITECT HBSAG/CONFIMATORY
Kit, Test, Alpha-Fetoprotein For Neural Tube Defects
FDA Pre-Market Approval
FDA Class 3
·ABBOTT AFP-EIA
Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)
FDA Pre-Market Approval
FDA Class 3
·ARCHITECT AUSAB (LN 1L82)
Test, Prostate Specific Antigen, Free, (Noncomplexed) To Distinguish Prostate Cancer From Benign Conditions
FDA Pre-Market Approval
FDA Class 3
·ARCHITECT Free PSA / Alinity i Free PSA
Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)
FDA Pre-Market Approval
FDA Class 3
·ARCHITECT HBSAG/CONFIRMATORY
Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)
FDA Pre-Market Approval
FDA Class 3
·ARCHITECT CORE-M
Test, Prostate Specific Antigen, Free, (Noncomplexed) To Distinguish Prostate Cancer From Benign Conditions
FDA Pre-Market Approval
FDA Class 3
·ARCHITECT FREE PSA
Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)
FDA Pre-Market Approval
FDA Class 3
·Alinity i Anti-HBc Reagent Kit, Alinity i Anti-HBc Calibrator, Alinity i Anti-HBc Controls
Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)
FDA Pre-Market Approval
FDA Class 3
·Alinity i Anti-HBc IgM Reagent Kit (2xl00 Tests)
Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)
FDA Pre-Market Approval
FDA Class 3
·ABBOTT ARCHITECT