BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

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

    PMA: P070006 · Supplement: S003 · Decision Mar 4, 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
    S003
    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
    March 4, 2010
    Date Received
    October 1, 2009
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR THE INSTITUTION OF THE USE OF SEMI-AUTOMATED SYSTEM FOR THE DISPENSING AND CAPPING STAGES IN THE PRODUCTION OF THE POSITIVE CONTROL, PANEL A REAGENT, AND PANEL B REAGENT OF THE T-SPOT.TB TEST KIT USING THE FF30 DISPENSER/CAPPER FROM FLEXICON. IN ADDITION, THE TYPE OF VIAL CAPS HAS BEEN CHANGED FROM A POPCAN CAP TO A HDPE CAP WHICH IS NOW GAMMA IRRADIATED RATHER THAN AUTOCLAVED TO REDUCE BACTERIAL AND FUNGAL CONTAMINATION.

    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