BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

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

    PMA: P070006 · Supplement: S023 · Decision Jun 4, 2024
    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
    S023
    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
    June 4, 2024
    Date Received
    March 6, 2024
    Supplement Type
    Real-Time Process
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    Approval for the use of in-house manufactured micro-well plates and the use of two alternative micro-well plate membranes in the manufacture of the T-SPOT.TB Test.

    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