BEUDAMED
    FDA PMA FDA Class 3 30-Day Notice Accepted 🇺🇸 United States

    System, Test, Tumor Marker, For Detection Of Bladder Cancer

    PMA: P940035 · Supplement: S011 · Decision Jul 28, 2015
    View on FDA
    Classifications
    1
    FEI Numbers
    4
    Registration Numbers
    4

    Basic Information

    Device Name
    System, Test, Tumor Marker, For Detection Of Bladder Cancer
    Trade Name
    ALERE NMP22 BLADDERCHEK TEST
    PMA Number
    P940035
    Supplement Number
    S011
    Device Class
    FDA Class 3
    Product Code
    NAH
    Generic Name
    System, test, tumor marker, for detection of bladder cancer
    Medical Specialty
    Unknown
    Advisory Committee
    Immunology
    Decision
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    July 28, 2015
    Date Received
    July 1, 2015
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    CHANGE IN THE MANUFACTURING PROCESS OF THE ALERE NMP22 BLADDERCHEK TEST, IN WHICH HEAT TREATED NORMAL MOUSE SERUM IS USED INSTEAD OF NORMAL MOUSE SERUM AS A CONTROL TEST LINE BLOCKING AGENT.

    Classifications

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

    Product Code Device Name
    NAH System, Test, Tumor Marker, For Detection Of Bladder Cancer