BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

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

    PMA: P790025 · Supplement: S006 · Decision May 17, 1996
    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 HBE (RDNA) EIA
    PMA Number
    P790025
    Supplement Number
    S006
    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
    May 17, 1996
    Date Received
    December 2, 1994
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL TO MODIFY THE PRODUCT LABELING TO ENHANCE THE SAFETY IN THE USE OF THE ABBOTT HBE (RDNA) EIA. THE LIMITATIONS SECTION WILL BE MODIFIED TOSTATE THAT "SAMPLES CONTAINING RHEUMATOID FACTOR AMY DEMONSTRATE FALSELY ELEVATED VALUES IN THE HBEAG ASSAY," AND THE INTERPRETATION OF RESULTS SECTION WILL BE MODIFIED TOSTATE THAT "IT IS RECOMMENDED THAT PATIENTS BE SCREENED FOR THE PRESENCE OF HBSAG PRIOR TO BEING EVALUATED FOR THE PRESENCE OF HBEAG."

    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)