Vitamin K Epoxide Reductase Complex Subunit One (Vkorc1) Genotyping System
Medical specialty
Hematology
Device class
2
Regulation number
864.7750
Review panel
HE
Implant
N
Life sustaining/supporting
N
GMP exempt
N
Third party review
Y
Summary malfunction reporting
Eligible
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.