ODV

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

Product code: ODV
Device name: Vitamin K Epoxide Reductase Complex Subunit One (Vkorc1) Genotyping System
Device class: Class 2
21 CFR: 21 CFR 864.7750
Medical specialty: Hematology
Marketing pathway: 510(K)
Flag: Third-party review eligible
510(k) clearances (all years, FDA): 1 (all years; only the last 3 years are listed here)

FDA classification 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.

Definition text from the FDA device classification database (U.S. federal government work, public domain).

Official FDA classification page: ODV

Classification and pathway per current FDA publications. Data from openFDA (CC0).