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U.S. Department of Health and Human Services

Product Classification

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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.
Physical State genotyping test system
Technical Method Uses DNA genotyping technology to determine patient genotype at the Vitamin k epoxide reductase complex subunit one (VKORC1) gene locus.
Target Area clinical samples (blood, saliva, buccal swab samples)
Regulation Medical Specialty Hematology
Review Panel Hematology
Product CodeODV
Premarket Review Office of In Vitro Diagnostics (OHT7)
Division of Immunology and Hematology Devices (DIHD)
Submission Type 510(k)
Regulation Number 864.7750
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review
Accredited Persons