BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    System, Test, Her-2/Neu, Ihc

    PMA: P990081 · Supplement: S012 · Decision Aug 21, 2012
    View on FDA
    Classifications
    1
    FEI Numbers
    7
    Registration Numbers
    7

    Basic Information

    Device Name
    System, Test, Her-2/Neu, Ihc
    Trade Name
    PATWAY HER-2/NEU (4B5) RABBIT MONOCLONAL PRIMARY ANTIBODY
    PMA Number
    P990081
    Supplement Number
    S012
    Device Class
    FDA Class 3
    Product Code
    MVC
    Generic Name
    SYSTEM, TEST, HER-2/NEU, IHC
    Medical Specialty
    Unknown
    Advisory Committee
    Pathology
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    August 21, 2012
    Date Received
    July 25, 2012
    Supplement Type
    Real-Time Process
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR AN EXTENSION OF SHELF LIFE OF THE IVIEW DAB DETECTIONKIT AND THE ULTRAVIEW DAB DETECTION KIT FOR THE PATHWAY ANTI-HER-2/NEU (4B5) RABBIT MONOCLONAL PRIMARY ANTIBODY.

    Classifications

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

    Product Code Device Name
    MVC System, Test, Her-2/Neu, Ihc