BEUDAMED
    FDA PMA FDA Class 3 30-Day Notice Accepted 🇺🇸 United States

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

    PMA: P050045 · Supplement: S003 · Decision Nov 10, 2011
    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
    S003
    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
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    November 10, 2011
    Date Received
    October 6, 2011
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    ADD AN ALTERNATE SUPPLIER OF TEXAS RED LABELED DCTP NUCLEOTIDE AND TO REPLACE AN IN-PROCESS QC PROCEDURE WITH A NEW QC TEST ON FFPE BREAST CANCER TISSUE.

    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