BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

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

    PMA: P030049 · Decision May 26, 2005
    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
    ADVIA CENTAUR HBSAG READY PACK REAGENTS/CONFIRMATORY READY PACK REAGENTS/QUALITY CONTROL MATERIAL
    PMA Number
    P030049
    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
    May 26, 2005
    Date Received
    November 28, 2003
    Expedited Review
    N
    Docket Number
    05M-0270

    Advisory Committee Statement

    APPROVAL FOR THE ADVIA CENTAUR HBSAG READYPACK REAGENTS, ADVIA CENTAUR HBSAG CONFIRMATORY READYPACK REAGENTS, AND ADVIA CENTAUR HBSAG QUALITY CONTROL MATERIAL: ADVIA CENTAUR HBSAG READY PACK INDICATIONS FOR USE: THE ADVIA CENTAUR HBSAG ASSAY IS AN IN VITRO IMMUNOASSAY FOR THE QUALITATIVE DETECTION OF HEPATITIS B SURFACE ANTIGEN (HBSAG) IN HUMAN SERUM AND PLASMA (POTASSIUM EDTA, LITHIUM OR SODIUM HEPARINIZED) USING THE ADVIA CENTAUR SYSTEM. THE ASSAY MAY BE USED IN CONJUNCTION WITH OTHER SEROLOGICAL AND CLINICAL INFORMATION TO DIAGNOSE INDIVIDUALS WITH ACUTE OR CHRONIC HEPATITIS B INFECTIONS. THE ASSAY MAY ALSO BE USED TO SCREEN FOR HEPATITIS B INFECTION IN PREGNANT WOMEN TO IDENTIFY NEONATES WHO ARE AT RISK OF ACQUIRING HEPATITIS B DURING THE PERINATAL PERIOD. ADVIA CENTAUR HBSAG CONFIRMATORY READY PACK INDICATION FOR USE: THE ADVIA CENTAUR HBSAG CONFIRMATORY ASSAY IS AN IN VITRO DIAGNOSTIC IMMUNOASSAY FOR THE QUALITATIVE CONFIRMATION OF THE PRESENCE OF HEPATITIS B SURFACE ANTIGEN (HBSAG) IN HUMAN SERUM OR PLASMA (EDTA, LITHIUM OR SODIUM HEPARIN) USING THE ADVIA CENTAUR SYSTEM. THE ASSAY IS INTENDED TO BE USED TO CONFIRM THE PRESENCE OF HBSAG IN SAMPLES THAT ARE REPEATEDLY REACTIVE USING THE ADVIA CENTAUR HBSAG ASSAY. ADVIA CENTAUR HBSAG QUALITY CONTROL MATERIAL INDICATIONS FOR USE: FOR MONITORING THE PERFORMANCE OF THE HBSAG AND HBSAG CONFIRMATORY ASSAYS ON THE ADVIA CENTAUR SYSTEMS.

    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)