ODVClass II
Vitamin K Epoxide Reductase Complex Subunit One (Vkorc1) Genotyping System
21 CFR 864.7750 / Hematology
ODV is the FDA product code for Vitamin K Epoxide Reductase Complex Subunit One (Vkorc1) Genotyping System, a class II device type, regulated under 21 CFR 864.7750. FDA's definition for this code reads: "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". As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and no recalls.
Classification record
- Product code
- ODV
- Device name
- Vitamin K Epoxide Reductase Complex Subunit One (Vkorc1) Genotyping System
- 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.
- Regulation
- 21 CFR 864.7750
- Device class
- Class II
- Review panel
- Hematology
- Submission type
- 510(k)
- Implant
- No
- Life sustaining or supporting
- No
- GMP exempt
- No
- Third party review eligible
- Yes
- Ingested clearances
- 1
- Ingested recalls
- 0
Clearances, product code ODV
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 2008 | 1 |
Applicants with the most clearances
Product code ODV| Applicant | Clearances |
|---|---|
| Paragondx, LLC | 1 |
Companies listing this code with FDA
Companies whose registered establishments list this codeFIRST ARTICLE / WEEKLY
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