BEUDAMED
    FDA PMA FDA Class 2 Approved 🇺🇸 United States

    System, Test, Carcinoembryonic Antigen

    PMA: P840019 · Supplement: S012 · Decision Mar 7, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    30
    Registration Numbers
    30

    Basic Information

    Device Name
    System, Test, Carcinoembryonic Antigen
    Trade Name
    TANDEM(R) E CEA IMMUNORADIOMETRIC ASSAY
    PMA Number
    P840019
    Supplement Number
    S012
    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
    March 7, 1996
    Date Received
    September 21, 1995
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    MODIFICATIONS TO THE HYBRITECH TANDEM-E CEA ASSAY WHITH ENHANCEMENTS IN THE FORMUALTION OF THE ALKALINE PHOSPHATASE-LABELED ANTI-CEA ANTIBODY CONJUGATE AND THE ADDTION OF THE BLOCKING REAGENT POLY MAK 33, A COPOLYMER OF INTACT AND FAB FRAGMENTED MOUSE ANTI-HUMAN CK-MM ANTIBODIES

    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