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

    Chromogenic In Situ Hybridization, Nucleic Acid Amplification, Her2/Neu Gene, Breast Cancer

    PMA: P100027 · Supplement: S022 · Decision Sep 11, 2015
    View on FDA
    Classifications
    1
    FEI Numbers
    1
    Registration Numbers
    1

    Basic Information

    Device Name
    Chromogenic In Situ Hybridization, Nucleic Acid Amplification, Her2/Neu Gene, Breast Cancer
    Trade Name
    INFORM HER-2 DUAL ISH DNA PROBE COCKTAIL
    PMA Number
    P100027
    Supplement Number
    S022
    Device Class
    FDA Class 3
    Product Code
    NYQ
    Generic Name
    Chromogenic in situ hybridization, nucleic acid amplification, HER2/NEU gene, breast cancer
    Medical Specialty
    Unknown
    Advisory Committee
    Pathology
    Decision
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    September 11, 2015
    Date Received
    August 14, 2015
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    ADDITION OF A NEW SUPPLIER OF A NOZZLE PLATE USED IN THE PRODUCTION OF THE BENCHMARK ULTRA INSTRUMENT, WHICH IS PART OF THE PMA SYSTEM FOR THE REAGENTS.

    Classifications

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

    Product Code Device Name
    NYQ Chromogenic In Situ Hybridization, Nucleic Acid Amplification, Her2/Neu Gene, Breast Cancer