FDA device listing
PRIME SCREEN® Single Panel Urine Test Cannabinoids (THC20),SAFElife™ T-Dip Multi-Drug Urine Test Panel Dx
FDA device listing 1552428860 · Wondfo USA Co., Ltd.
Key facts
| Proprietary names | PRIME SCREEN® Single Panel Urine Test Cannabinoids (THC20),SAFElife™ T-Dip Multi-Drug Urine Test Panel Dx |
|---|---|
| Owner/operator | Wondfo USA Co., Ltd. |
| Owner/operator number | 10028951 |
| Premarket submissions | K260065 |
| Product codes | LCM, NFT, NFV, NFW, NFY, NGG, NGL, PTG, PTH, QAW, QBF |
| Device names | LCM - Enzyme Immunoassay, Phencyclidine, NFT - Test, Amphetamine, Over The Counter, NFV - Test, Benzodiazepine, Over The Counter, NFW - Test, Cannabinoid, Over The Counter, NFY - Test, Cocaine And Cocaine Metabolites, Over The Counter, NGG - Test, Methamphetamine, Over The Counter, NGL - Test, Opiates, Over The Counter, PTG - Test, Methadone, Over The Counter, PTH - Test, Barbiturate, Over The Counter, QAW - Test, Tricyclic Antidepressants, Over The Counter, QBF - Test, Propoxyphene, Over The Counter |
| Device class | Class II, Unclassified |
| Classification regulations (21 CFR) | 862.3100, 862.3150, 862.3170, 862.3250, 862.3610, 862.3620, 862.3650, 862.3700, 862.3870, 862.3910, ORCA1.LCM |
| 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
- 10–99 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