BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

    PMA: P180045 · Decision Aug 29, 2020
    View on FDA
    Classifications
    1
    FEI Numbers
    27
    Registration Numbers
    27

    Basic Information

    Device Name
    Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)
    Trade Name
    LIAISON® XL MUREX HBc IgM, LIAISON® XL MUREX Control HBc IgM
    PMA Number
    P180045
    Device Class
    FDA Class 3
    Product Code
    LOM
    Generic Name
    Test, hepatitis b (b core, be antigen, be antibody, b core igm)
    Medical Specialty
    Unknown
    Advisory Committee
    Microbiology
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    August 29, 2020
    Date Received
    December 6, 2018
    Expedited Review
    N
    Docket Number
    20M-1828

    Advisory Committee Statement

    Approval for the LIAISON® XL MUREX HBc IgM and LIAISON® XL MUREX Control HBc IgM. The LIAISON® XL MUREX HBc IgM assay is an in vitro chemiluminescent immunoassay (CLIA) for the qualitative detection of IgM antibodies to hepatitis B virus core antigen (HBc IgM) in human adult and pediatric (2 to 21 years) serum and plasma (lithium and sodium heparin, sodium citrate and K2 EDTA), including separator tubes, on the LIAISON® XL Analyzer. Assay results, in conjunction with other hepatitis B virus (HBV) serological markers and clinical information may be used as an aid in the diagnosis of HBV infection in patients with symptoms of hepatitis or who may be at risk for HBV infection. The presence of anti-HBc IgM is indicative of acute or recent HBV infection.This assay is not approved for use in screening blood, plasma or tissue donors. The LIAISON® XL MUREX Control HBc IgM (negative and positive) is intended for use as assayed quality control samples to monitor the performance of the LIAISON® XL MUREX HBc IgM assay. The performance characteristics of LIAISON® XL MUREX Control HBc IgM have not been established for any other assays or instrument platforms.

    Classifications

    This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    LOM Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)