BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Test, Immunity, Cell Mediated, Mycobacterium Tuberculosis

    PMA: P010033 · Decision Nov 28, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    4
    Registration Numbers
    4

    Basic Information

    Device Name
    Test, Immunity, Cell Mediated, Mycobacterium Tuberculosis
    Trade Name
    QUANTTFERON-TB GOLD AND TB GOLD-IN-THE-TUBE
    PMA Number
    P010033
    Device Class
    FDA Class 3
    Product Code
    NCD
    Generic Name
    TEST, IMMUNITY, CELL MEDIATED, MYCOBACTERIUM TUBERCULOSIS
    Medical Specialty
    Unknown
    Advisory Committee
    Microbiology
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    November 28, 2001
    Date Received
    June 1, 2001
    Expedited Review
    Y
    Docket Number
    02M-0218

    Advisory Committee Statement

    APPROVAL FOR THE CELLESTIS QUANTIFERON-TB. THE DEVICE IS INDICATED FOR USE AS AN AID IN THE DETECTION OF INFECTION WITH MYCOBACTERIUM TUBERCULOSIS.

    Classifications

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

    Product Code Device Name
    NCD Test, Immunity, Cell Mediated, Mycobacterium Tuberculosis