BEUDAMED
    FDA PMA Approved 🇺🇸 United States

    PMA: P980046 · Decision Apr 28, 1999
    View on FDA
    Classifications
    0
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Trade Name
    HOME ACCESS HEPATITIS C CHECK AND HEPATITIS C CHECK EXPRESS
    PMA Number
    P980046
    Product Code
    QRO
    Generic Name
    Immunoassay for the detection of antibody to Hepatitis C Virus intended for over the counter use
    Advisory Committee
    Microbiology
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    April 28, 1999
    Date Received
    December 7, 1998
    Expedited Review
    Y
    Docket Number
    99M-2143

    Advisory Committee Statement

    Approval for the Home Access(R) Hepatitis C Check(SM) and Hepatitis C Check(SM) Express. This device is indicated for home use for collection of a dried blood spot speciment by finger-stick, and is indicated for anonymous testing for antibody to hepatitis C virus (HCV) in adults, eighteen years or older, who may have been exposed to HCV through transfusion or organ transplant before 1992, who may have injected non-prescription durgs, or who were exposed to infected needles or had sexual contacts with HCV infected individuals.