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Vitamin K Epoxide Reductase Complex Subunit One (Vkorc1) Genotyping System

FDA product code ODV · 1 cleared devices

Class 2 Hematology
Regulation
21 CFR 864.7750
Review panel
HE
Implant
No
Life sustaining
No
Third party review
Yes
GMP exempt
No
Clearance span
2008-04-28 – 2008-04-28

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.

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