BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

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

    PMA: P100027 · Supplement: S024 · Decision Apr 13, 2016
    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
    S024
    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
    April 13, 2016
    Date Received
    December 10, 2015
    Supplement Type
    135 Review Track For 30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    Approval for the following:1) Enlargement of a bulk formulation room at Ventana Medical Systems' Tucson, AZ facility; and 2) addition of two large volume tanks, along with supply plumbing, a clean in place (CIP) procedure, and new filler, as well as a new fill line.

    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