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

    Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

    PMA: P090008 · Decision Apr 29, 2010
    View on FDA
    Classifications
    1
    FEI Numbers
    24
    Registration Numbers
    24

    Basic Information

    Device Name
    Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus
    Trade Name
    ELECSYS ANTI-HCV IMMUNOASSAY & ELECSYS PRECICONTROL ANTI-HCV FOR USE ON COBAS E601 IMMUNOSSAY ANALYZER
    PMA Number
    P090008
    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 (Reclassification)
    Decision Code
    APRL
    Decision Date
    April 29, 2010
    Date Received
    May 15, 2009
    Expedited Review
    N
    Docket Number
    10M-0262

    Advisory Committee Statement

    APPROVAL FOR THE ELECSYSANTI-HCV IMMUNOASSAY & ELECSYS PRECICONTROL ANTI-HCV ASSAY FOR USE ON COBAS E 601IMMUNOASSAY ANALYZER. THIS DEVICE IS INDICATED FOR:ELECSYS ANTI-HCV IMMUNOASSAYTHE ROCHE ELECSYS ANTI-HCV ASSAY IS AN IN VITRO DIAGNOSTIC TEST FOR THE QUALITATIVEDETECTION OF TOTAL ANTIBODIES TO HEPATITIS C VIRUS (ANTI-HCV) IN HUMAN SERUM OR PLASMA(POTASSIUM EDTA, LITHIUM HEPARIN AND SODIUM HEPARIN). ASSAY RESULTS, IN CONJUNCTION WITHOTHER LABORATORY RESULTS AND CLINICAL INFORMATION, MAY BE USED TO AID IN THE PRESUMPTIVE DIAGNOSIS OF HCV INFECTION IN PERSONS WITH SIGNS AND SYMPTOMS OF HEPATITIS AND IN PERSONS AT RISK FOR HEPATITIS C INFECTION. THE TEST DOES NOT DETERMINE THE STATE OF INFECTION OR ASSOCIATED DISEASE. THE ELECTROCHEMILUMI-NESCENCE IMMUNOASSAY "ECLIA" IS INTENDED FOR USE ON THE COBAS E601 IMMUNOASSAY ANALYZER.

    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