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

    Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

    PMA: P030056 · Decision Dec 22, 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
    ADVIA CENTAUR HCV READY PACK REAGENTS, ADVIA CENTAUR HCV QUALITY CONTROL MATERIALS
    PMA Number
    P030056
    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
    December 22, 2004
    Date Received
    December 24, 2003
    Expedited Review
    N
    Docket Number
    05M-0478

    Advisory Committee Statement

    APPROVAL FOR THE ADVIA CENTAUR HCV. HCV READYPACK REAGENTS: THE ADVIA CENTAUR HCV ASSAY IS AN IN VITRO DIAGNOSTIC IMMUNOASSAY FOR THE QUALITATIVE DETERMINATION OF IMMUNOGLOBULIN G (IGG) ANTIBODIES TO HEPATITIS C VIRUS (HCV) IN HUMAN SERUM AND PLASMA (EDTA, LITHIUM OR SODIUM HEPARINIZED) USING THE ADVIA CENTAUR SYSTEM. THE ASSAY MAY BE USED IN CONJUNCTION WITH OTHER SEROLOGICAL AND CLINICAL INFORMATION TO AID IN THE DIAGNOSIS OF INDIVIDUALS WITH SYMPTOMS OF HEPATITIS AND IN INDIVIDUALS AT RISK FOR HEPATITIS C INFECTION. HCV QUALITY CONTROL MATERIALS: FOR IN VITRO DIAGNOSTIC USE IN MONITORING THE PERFORMANCE OF THE HCV ASSAY ON THE ADVIA CENTAUR SYSTEMS. THE PERFORMANCE OF THE HCV QUALITY CONTROL MATERIAL HAS NOT BEEN ESTABLISHED WITH ANY OTHER ANTI-HCV ASSAYS.

    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