BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Test, Immunity, Cell Mediated, Mycobacterium Tuberculosis

    PMA: P010033 · Supplement: S004 · Decision Aug 7, 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 ANALYSIS SOFTWARE PROGRAM
    PMA Number
    P010033
    Supplement Number
    S004
    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
    August 7, 2003
    Date Received
    February 28, 2003
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR THE USE OF THE QUANTIFERON-TB ANALYSIS SOFTWARE PROGRAM FOR USE WITH THE QUANTIFERON-TB TEST. THE DEVICE ACCESSORY WILL BE MARKETED UNDER THE TRADE NAME QUANTIFERON-TB ANALYSIS SOFTWARE PROGRAM AND IS INDICATED AS A STAND ALONE PROGRAM FOR ANALYSIS OF RAW EIA DATA AND CALCULATION OF QUANTIFERON-TB ASSAY RESULTS.

    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