FDA device listing
OralTox,O-Swab
FDA device listing 1490634754 · Premier Biotech, LLC
Key facts
| Proprietary names | OralTox,O-Swab |
|---|---|
| Owner/operator | Premier Biotech, LLC |
| Owner/operator number | 10057135 |
| Product codes | PUY |
| Device names | PUY - Test, Barbiturate, Employment And Insurance Testing, Exempt |
| Device class | Class II |
| Classification regulations (21 CFR) | 862.3150 |
| Review panels | Clinical Toxicology |
| Registered establishments | Premier Biotech, LLC |
| Establishment registrations | 3010800486 |
| FEI numbers | 3010800486 |
| Establishment operations | Complaint File Establishment, Specification Developer |
| 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