BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Test, Immunity, Cell Mediated, Mycobacterium Tuberculosis

    PMA: P010033 · Supplement: S048 · Decision Jan 24, 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
    S048
    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
    January 24, 2023
    Date Received
    September 30, 2022
    Supplement Type
    Real-Time Process
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    Approval of the addition of Sodium Heparin tubes as an alternative for blood collection in the workflow of the Quantiferon TB Gold Plus Test

    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