DeviceClearance

Product code ODV— Hematology

RAPID GENOTYPING ASSAY -CYP2C9 & VKORC1, MODEL CATALOG NO. 006+0203 GACTGA

Classification name
Vitamin K Epoxide Reductase Complex Subunit One (Vkorc1) Genotyping System
Device class
Class 2
Regulation
21 CFR 864.7750
Advisory panel
Hematology
Total cleared
1
First cleared
Most recent

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.”

— U.S. Food and Drug Administration, device classification record for product code ODV under 21 CFR 864.7750, via openFDA

Market context for product code ODV

FDA has cleared 1 device under product code ODV, all in 2008, filed by 1 applicant company. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Top applicants under product code ODV

Recent clearances under product code ODV

Data sourced from openFDA. This site is unofficial and independent of the FDA.