BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

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

    PMA: P070006 · Supplement: S007 · Decision Nov 23, 2011
    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
    S007
    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
    November 23, 2011
    Date Received
    November 17, 2011
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR THE ADDITION OF A NEW TEST KIT FORMAT WITH INCREASED REAGENT VOLUMES AND 50 ANTIBODY COATED 96-WELL MICROTITRE PLATES TO INCREASE THE KIT CAPACITY TO A TOTAL OF 1200 TESTS.

    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