BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Fluorescence In Situ Hybridization, Topoisomerase Ii Alpha, Gene Amplification And Deletion

    PMA: P050045 · Supplement: S001 · Decision Feb 13, 2008
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Device Name
    Fluorescence In Situ Hybridization, Topoisomerase Ii Alpha, Gene Amplification And Deletion
    Trade Name
    TOP2A FISH PHARMDX KIT
    PMA Number
    P050045
    Supplement Number
    S001
    Device Class
    FDA Class 3
    Product Code
    NXG
    Generic Name
    Fluorescence in situ hybridization, topoisomerase ii alpha, gene amplification and deletion
    Medical Specialty
    Unknown
    Advisory Committee
    Pathology
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    February 13, 2008
    Date Received
    January 28, 2008
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR MODIFICATION OF THE CEN 17 REFERENCE PNA PROBES AND ADJUSTMENT OF THE CONCENTRATION OF THE TOP2A GENE TARGETED DNA PROBES IN VIAL 3 PROBE MIX.

    Classifications

    This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    NXG Fluorescence In Situ Hybridization, Topoisomerase Ii Alpha, Gene Amplification And Deletion