Product code
ODV: Vitamin k epoxide reductase complex subunit one (vkorc1) genotyping system
FDA product code · Class II · Hematology
Key facts
| Product code | ODV |
|---|---|
| Device | Vitamin k epoxide reductase complex subunit one (vkorc1) genotyping system |
| Device class | Class II |
| Regulation number | 864.7750 |
| Review panel | Hematology |
| Medical specialty | Hematology |
| Submission type | 510(k) |
| GMP exempt | No |
| Implanted device | No |
| Life-sustaining or life-supporting | 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. |
At a glance
- 1–9 510(k) clearances
- None De Novo grants
- None PMA approvals
- None HDE approvals
- 1–9 UDI devices (GUDID)
- 1–9 MAUDE adverse event reports
- None Recalled products (Z-numbers)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device product codes
FDA product codes classify medical devices by type and intended use; each code maps to a device class, a classification regulation and a review panel.
Source: U.S. Food and Drug Administration (FDA), Product Classification database