BEUDAMED
    FDA PMA FDA Class 3 30-Day Notice Accepted 🇺🇸 United States

    Test, Immunity, Cell Mediated, Mycobacterium Tuberculosis

    PMA: P010033 · Supplement: S049 · Decision Dec 15, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    4
    Registration Numbers
    4

    Basic Information

    Device Name
    Test, Immunity, Cell Mediated, Mycobacterium Tuberculosis
    Trade Name
    QuantiFERON®-TB Gold Plus Test
    PMA Number
    P010033
    Supplement Number
    S049
    Device Class
    FDA Class 3
    Product Code
    NCD
    Generic Name
    TEST, IMMUNITY, CELL MEDIATED, MYCOBACTERIUM TUBERCULOSIS
    Medical Specialty
    Unknown
    Advisory Committee
    Microbiology
    Decision
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    December 15, 2023
    Date Received
    December 4, 2023
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    changing sample size for final QC testing

    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