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: S011 · Decision Oct 10, 2013
    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
    S011
    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
    October 10, 2013
    Date Received
    September 12, 2013
    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 TWO BIOCONJUGATES FOR THE ULTRAVIEW SISH DNP DETECTION KIT AND THE ULTRAVIEW RED ISH DIG DETECTION KIT. BOTH DETECTION KITS ARE PARTS OF THE INFORM HER2 DUAL ISH DNA PROBE COCKTAIL.

    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