BEUDAMED
    FDA PMA FDA Class 2 Approved 🇺🇸 United States

    Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

    PMA: P080027 · Supplement: S001 · Decision Feb 18, 2011
    View on FDA
    Classifications
    1
    FEI Numbers
    24
    Registration Numbers
    24

    Basic Information

    Device Name
    Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus
    Trade Name
    ORAQUICK HCV RAPID ANTIBODY TEST
    PMA Number
    P080027
    Supplement Number
    S001
    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
    Decision Code
    APPR
    Decision Date
    February 18, 2011
    Date Received
    August 3, 2010
    Supplement Type
    Panel Track
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N
    Docket Number
    11M-0132

    Advisory Committee Statement

    APPROVAL FOR THE ORAQUICK HCV RAPID ANTIBODY TEST IS A SINGLE-USE IMMUNOASSAY FOR THE QUALITATIVE DETECTION OF ANTIBODIES TO HEPATITIS C VIRUS (ANTI-HCV) IN FINGERSTICK WHOLE BLOOD SPECIMENS AND VENIPUNCTURE WHOLE BLOOD SPECIMENS (EDTA, SODIUM HEPARIN, LITHIUM HEPARIN, AND SODIUM CITRATE) FROM INDIVIDUALS 15 YEARS OR OLDER. THE ORAQUICK HCV RAPID ANTIBODY TEST RESULTS, IN CONJUNCTION WITH OTHER LABORATORY RESULTS AND CLINICAL INFORMATION, MAY BE USED TO PROVIDE PRESUMPTIVE EVIDENCE OF INFECTION WITH HCV (STATE OF INFECTION OR ASSOCIATED DISEASE NOT DETERMINED) IN PERSONS WITH SIGNS OR SYMPTOMS OF HEPATITIS AND IN PERSONS AT RISK FOR HEPATITIS C INFECTION.

    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