Product code
OTV: Research use only/clinical chemistry devices
FDA product code · Not Classified · Clinical Chemistry
Key facts
| Product code | OTV |
|---|---|
| Device | Research use only/clinical chemistry devices |
| Device class | Not Classified |
| Review panel | Clinical Chemistry |
| Submission type | Enforcement Discretion |
| GMP exempt | Yes |
| Definition | For research use only and for products imported into the US only. |
At a glance
- None 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