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    K Number
    K172133
    Device Name
    ADVIA Centaur Active-B12 (Holotranscobalamin) (AB12) Assay
    Manufacturer
    Axis-Shield Diagnostics Ltd.
    Date Cleared
    2017-10-27

    (105 days)

    Product Code
    CDD
    Regulation Number
    862.1810
    Why did this record match?
    Applicant Name (Manufacturer) :

    Axis-Shield Diagnostics Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ADVIA Centaur Active-B12 (Holotranscobalamin)(AB12) assay is for in vitro diagnostic use in the quantitative measurement of holotranscobalamin (holoTC) in human serum using the ADVIA Centaur XP system. Active-B12 (holotranscobalamin) is used as an aid in the diagnosis and treatment of vitamin B12 deficiency.
    Device Description
    The ADVIA Centaur AB12 assay is a fully automated, two-step direct immunoassay using chemiluminescent technology. The assay utilizes an acridinium ester-labeled anti-transcobalamin antibody as the Lite Reagent. The Solid Phase consists of biotinylated anti-holotranscobalamin antibody coupled to streptavidin-coated magnetic latex microparticles.
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