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510(k) Data Aggregation

    K Number
    K203833
    Device Name
    Tacrolimus Assay Kit
    Manufacturer
    Shanghai Genext Medical Technology Co., Ltd.
    Date Cleared
    2023-01-27

    (758 days)

    Product Code
    MLM
    Regulation Number
    862.1678
    Why did this record match?
    Applicant Name (Manufacturer) :

    Shanghai Genext Medical Technology Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Tacrolimus Assay Kit is used for quantitative determination of the tacrolimus concentration in human whole blood on the Beckman Coulter AU480. It is to be used as an aid in the management of liver and kidney allograft patients receiving tacrolimus therapy. For In Vitro Diagnostic Use.
    Device Description
    The Tacrolimus Assay Kit utilizes the latex-enhanced competitive immunoturbidimetry method for quantitative determination of the tacrolimus concentration in human whole blood. The assay consists of reagents, sample extract and calibrator.
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