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    K Number
    K940242
    Device Name
    VENTANA CEA PRIMARY ANTIBODY
    Manufacturer
    VENTANA MEDICAL SYSTEMS, INC.
    Date Cleared
    1996-12-23

    (1069 days)

    Product Code
    DFD
    Regulation Number
    866.5550
    Why did this record match?
    Product Code :

    DFD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Not Found
    Device Description
    Ventana Medical Systems, Inc. developed the Ventana CEA Primary Antibody for use on the Ventana ES automated slide staining system. Ventana CEA Primary Antibody (clone TF 3H8-1) is substantially equivalent to a commercially available anti-human cytokeratin (clone CAM 5.2) in that they both stain antigens on cells of epithelial origin.
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