BEUDAMED
    4,176 results · 70ms · Sources: EU EUDAMED, US FDA

    Kit, Test, Alpha-Fetoprotein For Neural Tube Defects

    FDA Pre-Market Approval
    FDA Class 3 ·ABBOTT AFP-EIA DIAGNOSTIC KIT

    Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

    FDA Pre-Market Approval
    FDA Class 2 ·AXSYM ANTI-HCV

    Total, Prostate Specific Antigen (Noncomplexed & Complexed) For Detection Of Prostate Cancer

    FDA Pre-Market Approval
    FDA Class 3 ·ARCHITECT Total PSA / Alinity i Total PSA

    Kit, Test, Alpha-Fetoprotein For Neural Tube Defects

    FDA Pre-Market Approval
    FDA Class 3 ·ARCHITECT AFP / Alinity i AFP

    Kit, Assay, Estrogen Receptor

    FDA Pre-Market Approval
    FDA Class 3 ·ABBOTT ER-EIA MONOCLONAL DIAG. KIT

    Kit, Test, Alpha-Fetoprotein For Neural Tube Defects

    FDA Pre-Market Approval
    FDA Class 3 ·ARCHITECT AFP assay

    Kit, Test,Alpha-Fetoprotein For Testicular Cancer

    FDA Pre-Market Approval
    FDA Class 2 ·ABBOTT AXSYM AFP

    Hepatitis A Test (Antibody And Igm Antibody)

    FDA Pre-Market Approval
    FDA Class 2 ·HAVAB-M DIAGNOSTIC KIT

    Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

    FDA Pre-Market Approval
    FDA Class 3 ·ARCHITECT CORE-M

    Total, Prostate Specific Antigen (Noncomplexed & Complexed) For Detection Of Prostate Cancer

    FDA Pre-Market Approval
    FDA Class 3 ·ARCHITECT TOTAL PSA AND AXSYM TOTAL PSA

    Sensor, Glucose, Invasive

    FDA Pre-Market Approval
    FDA Class 3 ·FREESTYLE NAVIGATOR CONTINUOUS GLUCOSE MONITORING SYSTEM

    Total, Prostate Specific Antigen (Noncomplexed & Complexed) For Detection Of Prostate Cancer

    FDA Pre-Market Approval
    FDA Class 3 ·ABBOTT IMX TOTAL PSA, ABBOTT AXSYM TOTAL PSA AND ABBOTT ARCHITECT TOTAL PSA

    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

    System, Test, Automated, Antimicrobial Susceptibility, Short Incubation

    FDA Pre-Market Approval
    FDA Class 2 ·ANTIMICROBIAL SUSCEPTABILITY TEST SYSTEM

    Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

    FDA Pre-Market Approval
    FDA Class 2 ·AXSYM ANTI-HCV

    Sensor, Glucose, Invasive

    FDA Pre-Market Approval
    FDA Class 3 ·FREESTYLE NAVIGATOR CONTINUOUS GLUCOSE MONITORING SYSTEM

    Total, Prostate Specific Antigen (Noncomplexed & Complexed) For Detection Of Prostate Cancer

    FDA Pre-Market Approval
    FDA Class 3 ·AXSYM TOTAL PSA

    Kit, Test, Alpha-Fetoprotein For Neural Tube Defects

    FDA Pre-Market Approval
    FDA Class 3 ·ARCHITECT AFP

    Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

    FDA Pre-Market Approval
    FDA Class 3 ·ARCHITECT CORE Reagent Kit, Alinity i Anti-HBc Reagent Kit

    Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

    FDA Pre-Market Approval
    FDA Class 3 ·ABBOTT ARCHITECT CORE ASSAY