BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    System, Test, Her-2/Neu, Ihc

    PMA: P990081 · Supplement: S008 · Decision Nov 17, 2010
    View on FDA
    Classifications
    1
    FEI Numbers
    7
    Registration Numbers
    7

    Basic Information

    Device Name
    System, Test, Her-2/Neu, Ihc
    Trade Name
    PATHWAY ANTI-HER 2INEU (4B5) RABBIT MONOCLONAL PRIMARY ANTIBODY
    PMA Number
    P990081
    Supplement Number
    S008
    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
    November 17, 2010
    Date Received
    October 21, 2010
    Supplement Type
    Special (Immediate Track)
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR CHANGES IN QUALITY CONTROLS TO ENSURE THE SAFETY IN THE USE OF THE DEVICE BY: 1) ADDING A TEST TO ENSURE APPROPRIATE STAIN INTENSITY OF THE PRIMARY ANTIBODY AT THE BULK MANUFACTURING STAGES; AND 2) ADDING A QUALITY CONTROL TESTING STEPS AT THE RAW MATERIAL PRODUCTION AND BULK MANUFACTURING STAGES.

    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