BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Test, Immunity, Cell Mediated, Mycobacterium Tuberculosis

    PMA: P180047 · Supplement: S039 · Decision Jan 26, 2026
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Device Name
    Test, Immunity, Cell Mediated, Mycobacterium Tuberculosis
    Trade Name
    LIAISON QuantiFERON TB Gold Plus II; LIAISON Control QuantiFERON TB Gold Plus II
    PMA Number
    P180047
    Supplement Number
    S039
    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 26, 2026
    Date Received
    July 30, 2025
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    Approval for changes to the formulation of antibody and buffer reagents, changes to the assay component layout, changes to the assay protocol, introduction of the new trade name LIAISON QuantiFERON - TB Gold Plus II, LIAISON Control QuantiFERON - TB Gold Plus II, the addition of new suppliers for raw materials, and revisions to packaging and device labeling.

    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