FDA device listing
Cocaine(COC) Rapid Test, EMPLOYMENT AND INSURANCE TESTING, EXEMPT
FDA device listing 1420465660 · Hangzhou Tongzhou Biotechnology Co., Ltd
Key facts
| Proprietary names | Cocaine(COC) Rapid Test, EMPLOYMENT AND INSURANCE TESTING, EXEMPT |
|---|---|
| Owner/operator | Hangzhou Tongzhou Biotechnology Co., Ltd |
| Owner/operator number | 10084418 |
| Product codes | PVA |
| Device names | PVA - Test, Cocaine And Cocaine Metabolite, Employment And Insurance Testing, Exempt |
| Device class | Class II |
| Classification regulations (21 CFR) | 862.3250 |
| Review panels | Clinical Toxicology |
| Registered establishments | HANGZHOU TONGZHOU BIOTECHNOLOGY CO., LTD |
| Establishment registrations | 3021986677 |
| FEI numbers | 3021986677 |
| 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