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510(k) Data Aggregation

    K Number
    K071867
    Device Name
    RAPID GENOTYPING ASSAY -CYP2C9 & VKORC1, MODEL CATALOG NO. 006+0203 GACTGA
    Manufacturer
    PARAGONDX, LLC
    Date Cleared
    2008-04-28

    (297 days)

    Product Code
    ODV, ODW
    Regulation Number
    864.7750
    Why did this record match?
    Applicant Name (Manufacturer) :

    PARAGONDX, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Rapid Genotyping Assay - CYP2C9 & VKORC1 is intended to be used as an in vitro diagnostic test kit that detects the presence of CYP2C9 *2 and *3 and VKORC1 1173 C>T alleles. This test is for use with EDTA-anticoagulated whole blood samples. Information about the CYP2C9 and VKORC1 genotypes may be used as an aid in the identification of patients with greater risk for warfarin sensitivity.
    Device Description
    Not Found
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