BEUDAMED
    FDA PMA FDA Class 2 Approved 🇺🇸 United States

    System, Test, Carcinoembryonic Antigen

    PMA: P920021 · Supplement: S001 · Decision Feb 23, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    30
    Registration Numbers
    30

    Basic Information

    Device Name
    System, Test, Carcinoembryonic Antigen
    Trade Name
    OPUS(R) CEA TEST SYSTEM
    PMA Number
    P920021
    Supplement Number
    S001
    Device Class
    FDA Class 2
    Product Code
    DHX
    Generic Name
    SYSTEM, TEST, CARCINOEMBRYONIC ANTIGEN
    Regulation Number
    866.6010
    Medical Specialty
    Immunology
    Advisory Committee
    Immunology
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    February 23, 1996
    Date Received
    July 3, 1995
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL TO ADD THE CEA TEST SYSTEM TO THE OPUS PLUS AND OPUS MAGNUM ANALYZERS. THE SAME TEST SYSTEM IS USED ON ALL THREE INSTRUMENTS

    Classifications

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

    Product Code Device Name
    DHX System, Test, Carcinoembryonic Antigen