FDA device listing
OMNIgene ORAL (OM-505; OME-505),ORAcollect RNA (ORE-100)
FDA device listing 1405756534 · DNA GENOTEK, INC.
Key facts
| Proprietary names | OMNIgene ORAL (OM-505; OME-505),ORAcollect RNA (ORE-100) |
|---|---|
| Owner/operator | DNA GENOTEK, INC. |
| Owner/operator number | 9054962 |
| Product codes | LIO |
| Device names | LIO - Device, Specimen Collection |
| Device class | Class I |
| Classification regulations (21 CFR) | 866.2900 |
| Review panels | Microbiology |
| Registered establishments | DNA GENOTEK, INC. |
| Establishment registrations | 3003742580 |
| FEI numbers | 3003742580 |
| Establishment operations | Manufacturer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- None listed Premarket submission listed
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device listings
Establishments that make or process devices for the U.S. market must list each device with the FDA. A listing records the device's proprietary names, product codes and premarket submission, and every registered establishment that handles it.
Source: U.S. Food and Drug Administration (FDA), Establishment Registration and Device Listing database