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510(k) Data Aggregation

    K Number
    K063224
    Device Name
    GENTRISURE HUMAN GENOMIC DNA REFERENCE CONTROL
    Manufacturer
    GENTRIS CORPORATION
    Date Cleared
    2006-12-22

    (59 days)

    Product Code
    NZB
    Regulation Number
    866.5910
    Why did this record match?
    Applicant Name (Manufacturer) :

    GENTRIS CORPORATION

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The GentriSure™ Human Genomic DNA Reference Control (HGDRC) is an independent. external run control that is intended for use in assessing the performance of diagnostic assays that detect cytochrome p450 2D6 (CYP2D6) genetic polymorphisms. This control is not intended to be used as a substitute for controls provided with licensed test kits. GentriSure HGDRC can be used for assay validation, staff training and proficiency testing, and as a quality control in routine in vitro diagnostic testing.
    Device Description
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