BEUDAMED
    FDA PMA FDA Class 2 Approved (Withdrawn) 🇺🇸 United States

    Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

    PMA: P970027 · Decision Feb 5, 2004
    View on FDA
    Classifications
    1
    FEI Numbers
    24
    Registration Numbers
    24

    Basic Information

    Device Name
    Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus
    Trade Name
    ABBOTT AXSYM ANTIBODY TO HCV
    PMA Number
    P970027
    Device Class
    FDA Class 2
    Product Code
    MZO
    Generic Name
    Assay, enzyme linked immunosorbent, hepatitis c virus
    Medical Specialty
    Unknown
    Advisory Committee
    Microbiology
    Decision
    Approved (Withdrawn)
    Decision Code
    APWD
    Decision Date
    February 5, 2004
    Date Received
    July 1, 1997
    Expedited Review
    N
    Docket Number
    04M-0207

    Advisory Committee Statement

    APPROVAL FOR THE ABBOTT AXSYM ANTIBODY TO HCV. THE DEVICE IS INDICATED FOR THE QUALITATIVE DETECTION OF ANTI-HCV RECOMBINANT PROTEINS IN HUMAN SERUM OR PLASMA (POTASSIUM EDTA, SODIUM EDTA, SODIUM HEPARIN, LITHIUM HEPARIN, SODIUM CITRATE, AND POTASSIUM OXALATE).

    Classifications

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

    Product Code Device Name
    MZO Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus