ODV — Vitamin K Epoxide Reductase Complex Subunit One (Vkorc1) Genotyping System Class II
FDA product code ODV covers "Vitamin K Epoxide Reductase Complex Subunit One (Vkorc1) Genotyping System", a Class II medical device regulated under 21 CFR 864.7750. Submissions are reviewed by the Hematology panel. At least 1 recent 510(k) clearance has been granted under this product code.
Classification Details
- Product Code
- ODV
- Device Class
- Class II
- Regulation Number
- 864.7750
- Submission Type
- Review Panel
- HE
- Medical Specialty
- Hematology
- Implant
- No
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.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K071867 | paragondx | RAPID GENOTYPING ASSAY -CYP2C9 & VKORC1, MODEL CATALOG NO. 006+0203 GACTGA | April 28, 2008 |