BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

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

    PMA: P050049 · Supplement: S008 · Decision Nov 14, 2011
    View on FDA
    Classifications
    1
    FEI Numbers
    27
    Registration Numbers
    27

    Basic Information

    Device Name
    Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)
    Trade Name
    ABBOTT AXSYM HBSAG
    PMA Number
    P050049
    Supplement Number
    S008
    Device Class
    FDA Class 3
    Product Code
    LOM
    Generic Name
    Test, hepatitis b (b core, be antigen, be antibody, b core igm)
    Medical Specialty
    Unknown
    Advisory Committee
    Microbiology
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    November 14, 2011
    Date Received
    August 1, 2011
    Supplement Type
    135 Review Track For 30-Day Notice
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR A CHANGE TO A SUPPLIER FOR AN INCOMING RAW MATERIAL, NONFAT DRY MILK (NFDM) THAT IS A COMPONENT OF THE AXSYM HBSAG CONJUGATE DILUENT IN THE AXSYM HBSAG REAGENT PACK IN THE AXSYM HBSAG ASSAY.

    Classifications

    This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    LOM Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)