BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Test, Immunity, Cell Mediated, Mycobacterium Tuberculosis

    PMA: P010033 · Supplement: S003 · Decision Mar 17, 2003
    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
    PMA Number
    P010033
    Supplement Number
    S003
    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
    March 17, 2003
    Date Received
    February 20, 2003
    Supplement Type
    Special (Immediate Track)
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR LABELING CHANGES TO THE INSTRUCTIONS FOR USE THAT ENHANCE THE SAFE USE OF THE QUANTIFERON-TB BY INCORPORATING RECOMMENDATIONS FROM THE "CDC GUIDELINES FOR USING THE QUANTIFERON-TB TEST FOR DIAGNOSING LATENT MYCOBACTERIUM TUBERCULOSIS INFECTION" (MMWR DISPATCH, VOL. 51/DECEMBER 18, 2002).

    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