BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Mycobacterium Tuberculosis, Cell Mediated Immune Response, Enzyme-Linked Immunospot Test

    PMA: P070006 · Supplement: S020 · Decision Dec 12, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    1
    Registration Numbers
    1

    Basic Information

    Device Name
    Mycobacterium Tuberculosis, Cell Mediated Immune Response, Enzyme-Linked Immunospot Test
    Trade Name
    T-SPOT. TB TEST
    PMA Number
    P070006
    Supplement Number
    S020
    Device Class
    FDA Class 3
    Product Code
    OJN
    Generic Name
    Mycobacterium tuberculosis, Cell mediated immune response, enzyme-linked immunospot test
    Medical Specialty
    Unknown
    Advisory Committee
    Microbiology
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    December 12, 2023
    Date Received
    May 26, 2023
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    Approval for the use of a new pair of recombinant mouse monoclonal IgG anti-human IFN-gamma antibodies manufactured by an additional third paty supplier (Absolute Antibody Ltd.) with the T-SPOT.TB test kit

    Classifications

    This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    OJN Mycobacterium Tuberculosis, Cell Mediated Immune Response, Enzyme-Linked Immunospot Test