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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device vitamin k epoxide reductase complex subunit one (vkorc1) genotyping system
Regulation Description Prothrombin time test.
Definition An in vitro diagnostic assay for use in genotyping vitamin k epoxide reductase complex subunit one (VKORC1) alleles to aid in the identification of patients at risk for altered warfarin sensitivity.
Product CodeODV
Regulation Number 864.7750
Device Class 2