BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

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

    PMA: P990012 · Supplement: S006 · Decision Oct 30, 2008
    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
    ELECSYS HBSAG TEST SYSTEM
    PMA Number
    P990012
    Supplement Number
    S006
    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
    October 30, 2008
    Date Received
    April 30, 2008
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL TO EXTEND APPLICATION OF THE ELECSYS HBSAG AND ELECSYS ANTI-HBS TEST SYSTEMS ONTO THE UPDATED VERSION OF THE MODULAR ANALYTICS E170 ANALYZER KNOWN AS THE COBAS E 601 ANALYZER. WHILE THE MODULAR ANALYTICS MODULAR SYSTEM INTEGRATES THE E170 MODULE WITH CLINICAL CHEMISTRY MODULES P OR D, THE COBAS E 601 IMMUNOASSAY ANALYZER IS A COMPONENT OF THE C6000 MODULAR SYSTEM WHICH INTEGRATES IMMUNOLOGY TESTING WITH THE COBAS C 501 CLINICAL CHEMISTRY ANALYSER. THERE HAVE BEEN NO CHANGES TO THE COMPOSITION OF ANY OF TE TEST SYSTEM REAGENTS (IMMUNOASSAY, CONTROLS OR CONFIRMATORY TEST), THE APPLICATION PARAMETERS, THE ANALYZER¿S ANALYTICAL MEASURING COMPONENT OR HOW THE RESULTS ARE CALCULATED. THE INDICATIONS FOR USE OF THE TWO TEST SYSTEMS REMAIN THE SAME.

    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)