FDA device listing
AllTest Fentanyl Rapid Test (Urine),Atida Fentanyl Drug of Abuse Test Rx,CHOSEN Fentanyl Urine Rapid Test Cassette…
FDA device listing 1685821839 · Hangzhou AllTest Biotech Co.,Ltd
Key facts
| Proprietary names | AllTest Fentanyl Rapid Test (Urine),Atida Fentanyl Drug of Abuse Test Rx,CHOSEN Fentanyl Urine Rapid Test Cassette Rx,Discover Fentanyl Rapid Test Cassette Rx,Fentanyl Test (Urine),HINDERING Fentanyl Rapid Test,Rapid Response Fentanyl Test Cassette (Urine),TZcheck Fentanyl Rapid Test |
|---|---|
| Owner/operator | Hangzhou AllTest Biotech Co.,Ltd |
| Owner/operator number | 10050156 |
| Premarket submissions | K231698 |
| Product codes | DJG |
| Device names | DJG - Enzyme Immunoassay, Opiates |
| Device class | Class II |
| Classification regulations (21 CFR) | 862.3650 |
| Review panels | Clinical Toxicology |
| Registered establishments | Hangzhou AllTest Biotech Co.,Ltd |
| Establishment registrations | 3012073813, 3027519599, 3043127647 |
| FEI numbers | 3012073813, 3027519599, 3043127647 |
| Establishment operations | Manufacturer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- 100–999 UDI devices (GUDID) under the same submission
- 10–99 Device listings citing the same submission
- Yes 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