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

    Hepatitis A Test (Antibody And Igm Antibody)

    PMA: P040018 · Decision Dec 22, 2004
    View on FDA
    Classifications
    1
    FEI Numbers
    24
    Registration Numbers
    24

    Basic Information

    Device Name
    Hepatitis A Test (Antibody And Igm Antibody)
    Trade Name
    ADVIA CENTAUR HAV IGM READY PACK REAGENTS, ADVIA CENTAUR HAV IGM QUALITY CONTROL MATERIALS
    PMA Number
    P040018
    Device Class
    FDA Class 2
    Product Code
    LOL
    Generic Name
    Hepatitis a test (antibody and igm antibody)
    Regulation Number
    866.3310
    Medical Specialty
    Microbiology
    Advisory Committee
    Microbiology
    Decision
    Approved (Reclassification)
    Decision Code
    APRL
    Decision Date
    December 22, 2004
    Date Received
    April 1, 2004
    Expedited Review
    N
    Docket Number
    05M-0129

    Advisory Committee Statement

    APPROVAL FOR THE ADVIA CENTAUR HAV IGM. HAV IGM READYPACK REAGENTS: THIS DEVICE IS INDICATED FOR USE FOR THE ADVIA CENTAUR HAV IGM ASSAY AND IS AN IN VITRO DIAGNOSTIC IMMUNOASSAY FOR THE QUALITATIVE DETERMINATION OF IGM RESPONSE TO THE HEPATITIS A VIRUS (HAV) IN HUMAN SERUM OR PLASMA (POTASSIUM EDTA, LITHIUM OR SODIUM HEPARINIZED) USING THE ADVIA CENTAUR SYSTEM. THE ASSAY IS INTENDED FOR USE AS AN AID IN THE DIAGNOSIS OF ACUTE OR RECENT INFECTION (USUALLY 6 MONTHS OR LESS) WITH HEPATITIS A VIRUS. HAV IGM QUALITY CONTROL MATERIALS: THE CONTROLS ARE INDICATED FOR IN VITRO DIAGNOSTIC USE IN MONITORING THE PERFORMANCE OF THE HAV IGM ASSAY ON THE ADVIA CENTAUR SYSTEMS. THE PERFORMANCE OF THE HAV IGM QUALITY CONTROL MATERIAL HAS NOT BEEN ESTABLISHED WITH ANY OTHER ANTI-HAV IGM ASSAYS.

    Classifications

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

    Product Code Device Name
    LOL Hepatitis A Test (Antibody And Igm Antibody)