BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

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

    PMA: P010050 · Supplement: S007 · Decision Feb 9, 2009
    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
    IMMULITE & IMMULITE 2000 HBSAG ASSAY
    PMA Number
    P010050
    Supplement Number
    S007
    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
    February 9, 2009
    Date Received
    December 2, 2008
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR REPLACEMENT OF THE SODIUM BASED BUFFER WITH POTASSIUM PHOSPHATEBUFFER AND ADDITION OF 2.0% NORMAL MOUSE SERUM AND 1.2% E-AMINO-N-CAPROIC ACID IN REAGENT A,AND THE ADDITION OF 0.2% SODIUM HEPARIN IN REAGENT B FOLLOWED BY REFILTERING OF DILUENT, AND ISINDICATED FOR IN VITRO DIAGNOSTIC USE FOR THE LABORATORY DIAGNOSIS OF ACUTE AND CHRONIC HEPATITIS BVIRUS INFECTIONS IN CONJUNCTION WITH OTHER SEROLOGICAL AND CLINICAL INFORMATION.

    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)