BEUDAMED
    496 results · 32ms · Sources: EU EUDAMED, US FDA
    Filters Classification: FDA Class 3 ×

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

    FDA Pre-Market Approval
    FDA Class 3 ·ARCHITECT CORE (LN 6L22)

    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 ·Alinity i Free PSA

    Sensor, Glucose, Invasive

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

    Sensor, Glucose, Invasive

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

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

    FDA Pre-Market Approval
    FDA Class 3 ·ARCHITECT HBsAg Qualitative Reagent, ARCHITECT HBsAg Qualitative Confirmatory Reagent, Alinity i HBsAg Qualitative II Re

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

    FDA Pre-Market Approval
    FDA Class 3 ·ABBOTT ARCHITECT HBSAG QUALITATIVE/ ARCHITECT HBSAG QUALITATIVE 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 ·AXSYM FREE PSA (LN 3C20)

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

    FDA Pre-Market Approval
    FDA Class 3 ·ARCHITECT CORE-M / Alinity i Anti-HBc IgM

    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

    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 CORE

    Sensor, Glucose, Invasive

    FDA Pre-Market Approval
    FDA Class 3 ·FREESTYLE NAVIGATOR

    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, 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

    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

    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