BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

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

    PMA: P190017 · 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 HBsAg Qual, LIAISON® MUREX Control HBsAg, and LIAISON® XL MUREX HBsAg Confirmatory Test
    PMA Number
    P190017
    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
    June 28, 2019
    Expedited Review
    N
    Docket Number
    20M-1829

    Advisory Committee Statement

    Approval for the LIAISON® XL MUREX HBsAg Qual, LIAISON® MUREX Control HBsAg, and LIAISON® XL MUREX HBsAg Confirmatory Test. The LIAISON® XL MUREX HBsAg Qual assay is an in vitro chemiluminescent immunoassay for the qualitative detection of hepatitis B surface antigen (HBsAg) in human adult and pediatric (2 to 21 years) serum and plasma (lithium and sodium heparin, sodium citrate and potassium EDTA) including separator tubes, on the LIAISON® XL Analyzer. Assay results in conjunction with other hepatitis B virus (HBV) serological 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 assay may also be used to screen for HBV infection in pregnant women to identify neonates who are at risk for acquiring hepatitis B during the perinatal period.The LIAISON® XL MUREX Control HBsAg Qual (negative and positive) is intended for use as assayed quality control samples to monitor the performance of the LIAISON® XL MUREX HBsAg Qual assay. The performance characteristics of LIAISON® controls have not been established for any other assays or instrument platforms different from LIAISON® XL.For details, refer to the Analyzer Operator's Manual.The LIAISON® XL MUREX HBsAg Confirmatory is an in vitro neutralization assay for confirmation of the presence of hepatitis B surface antigen (HBsAg) in human serum and plasma samples found repeatedly reactive for HBsAg by the LIAISON® XL MUREX HBsAg Qual ([REF] 318250).

    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)