BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

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

    PMA: P070006 · Supplement: S009 · Decision Jun 12, 2013
    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
    S009
    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 12, 2013
    Date Received
    September 4, 2012
    Supplement Type
    135 Review Track For 30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR THE ADDITION OF A SECOND APPROVED SUPPLIER FOR THE CONJUGATED SECONDARY ANTIBODY

    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