ODVClass II
Vitamin K Epoxide Reductase Complex Subunit One (vkorc1) Genotyping System
Hematology · 21 CFR 864.7750
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.
MDR events3All time
Recalls0All time
Registered firms2Currently listed
510(k) clearances1All time
Recent MDR events
3 adverse event reports on file
Event type breakdown
Injury3
Most-reported manufacturers
Recalls
0 recall events for this product code
No recalls on file for this product code.
Registered firms
2 firms currently registered for this product code
510(k) clearances
1 clearances for this product code