FDA device listing
O-Trust Oral Fluid Multi-Drug Test Card(Colloidal Gold),O-Trust Plus Oral Fluid Multi-Drug Test Cup(Colloidal…
FDA device listing 2035256490 · Eterbio, Inc.
Key facts
| Proprietary names | O-Trust Oral Fluid Multi-Drug Test Card(Colloidal Gold),O-Trust Plus Oral Fluid Multi-Drug Test Cup(Colloidal Gold),O-Trust SE Oral Fluid Multi-Drug Test Cup(Colloidal Gold),S-Trust Oral Fluid Multi-Drug Test Card(Colloidal Gold),S-Trust Plus Oral Fluid Multi-Drug Test Cup(Colloidal Gold),S-Trust SE Oral Fluid Multi-Drug Test Cup(Colloidal Gold) |
|---|---|
| Owner/operator | Eterbio, Inc. |
| Owner/operator number | 10091094 |
| Product codes | PVD |
| Device names | PVD - Test, Methamphetamine, Employment And Insurance Testing, Exempt |
| Device class | Class II |
| Classification regulations (21 CFR) | 862.3610 |
| Review panels | Clinical Toxicology |
| Registered establishments | ETERBIO, INC. |
| Establishment registrations | 3032147516 |
| FEI numbers | 3032147516 |
| 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