BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

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

    PMA: P100027 · Supplement: S007 · Decision Jul 23, 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 HER2 DUAL ISH DNA PROBE COCKTAIL
    PMA Number
    P100027
    Supplement Number
    S007
    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
    Approved
    Decision Code
    APPR
    Decision Date
    July 23, 2013
    Date Received
    March 12, 2013
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR MODIFICATIONS IN DESIGN TO PREVENT WASTE SYSTEM OVERFLOW OR OTHER LEAKS FROM CAUSING SHORTING CONDITIONS WITH THE BENCHMARK ULTRAS INTERNAL CIRCUITS.

    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