BEUDAMED
    FDA PMA Approved (Withdrawn) 🇺🇸 United States

    PMA: P990045 · Decision Mar 30, 2001
    View on FDA
    Classifications
    0
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Trade Name
    DIASORIN ETI-AB-COREK PLUS ASSAY
    PMA Number
    P990045
    Advisory Committee
    Microbiology
    Decision
    Approved (Withdrawn)
    Decision Code
    APWD
    Decision Date
    March 30, 2001
    Date Received
    July 2, 1999
    Expedited Review
    N
    Docket Number
    01M-0456

    Advisory Committee Statement

    APPROVAL FOR THE DIASORIN ETI-AB-COREK PLUS ASSAY. THE DEVICE IS INDICATED FOR: ETI-AB-COREK PLUS IS IAN IN VITRO ENZYME IMMUNOASSAY (EIA) INTENDED FOR USE IN THE QUALITATIVE DETERMINATION OF TOTAL ANTIBODIES TO HEPATITIS B CORE ANTIGEN (ANTI-HBC) IN HUMAN SERUM OR PLASMA (EDTA, CITRATE OR HEPARIN). THE ETI-AB-COREK PLUS IS INTENDED FOR MANUAL USE AND WITH THE BIOCHEM IMMUNOSYSTEMS LABOTECH/ETI-LAB AUTOMATED INSTRUMENT. THE DETECTION OF TOTAL ANTI-HBC IS INDICATIVE OF A LABORATORY DIAGNOSIS FOR EXPOSURE TO HEPATITIS B VIRUS (HBV) INFECTION . FURTHER HBV SEROLOGICAL MARKER TESTING IS REQUIRED TO DEFINE THE SPECIFIC DISEASE STATE. THE ETI-AB-COREK PLUS ASSAY'S PERFORMANCE HAS NOT BEEN ESTABLISHED FOR THE MONITORING OF HBV DISEASE OR THERAPY.