BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

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

    PMA: P070006 · Supplement: S001 · Decision Jul 9, 2010
    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
    S001
    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
    July 9, 2010
    Date Received
    February 27, 2009
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR THE USE OF T-CELL XTEND REAGENT WITH THE T-SPOT.TB TEST, IN ORDER TO EXTEND THE TIME FROM SAMPLE COLLECTION TO SAMPLE PROCESSING FROM WITHIN 8 HOURS OF VENIPUNCTURE TO BETWEEN 23 AND 30 HOURS POST VENIPUNCTURE; AND TO MAKE A TECHNICAL CORRECTION TO THE T-SPOT.TB TEST PACKAGE INSERT TO CHANGE THE NUMBER OF BLOOD COLLECTION TUBES REQUIRED FROM (2) 6 ML HEPARIN TUBES TO (1) 6 ML HEPARIN TUBE. THE T-CELL XTEND REAGENT IS INDICATED FOR USE WITH THE T-SPOT.TB TEST FOR THE PRE-TREATMENT OF WHOLE BLOOD PRIOR TO LYMPHOCYTE SEPARATION . THE REAGENT AIDS IN THE REMOVAL OF SELECTED WHITE BLOOD CELLS FROM WHOLE BLOOD STORED AT ROOM TEMPERATURE (18-25 DEGREES C).

    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