FDA device listing
PRIME SCREEN® Cannabinoids (THC) Urine Test Strip,PRIME SCREEN® Marijuana (THC) Urine Test Strip,SAFElife™ Cannabinoids…
FDA device listing 2015823800 · Wondfo USA Co., Ltd.
Key facts
| Proprietary names | PRIME SCREEN® Cannabinoids (THC) Urine Test Strip,PRIME SCREEN® Marijuana (THC) Urine Test Strip,SAFElife™ Cannabinoids (THC) Urine Test |
|---|---|
| Owner/operator | Wondfo USA Co., Ltd. |
| Owner/operator number | 10028951 |
| Premarket submissions | K110182 |
| Product codes | LDJ |
| Device names | LDJ - Enzyme Immunoassay, Cannabinoids |
| Device class | Class II |
| Classification regulations (21 CFR) | 862.3870 |
| Review panels | Clinical Toxicology |
| Registered establishments | WONDFO USA CO., LTD. |
| Establishment registrations | 3007606081 |
| FEI numbers | 3007606081 |
| Establishment operations | Complaint File Establishment |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- 1–9 UDI devices (GUDID) under the same submission
- 1–9 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