ODV
1 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Vitamin K Epoxide Reductase Complex Subunit One (Vkorc1) Genotyping System
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 864.7750
- Medical specialty
- Hematology
- Flags
- Third-party review eligible
- FDA 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.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| RAPID GENOTYPING ASSAY -CYP2C9 & VKORC1, MODEL CATALOG NO. 006+0203 GACTGA (K071867) | Paragondx, LLC | 2008-04-28 |
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