FDA device listing
2SAN Home Drug Test Kit,Areta Multi-Drug Test Cup,Areta Multi-Drug Test Cup, ACDOA-1144,Areta Multi-Drug Test Cup…
FDA device listing 1859928181 · Wondfo USA Co., Ltd.
Key facts
| Proprietary names | 2SAN Home Drug Test Kit,Areta Multi-Drug Test Cup,Areta Multi-Drug Test Cup, ACDOA-1144,Areta Multi-Drug Test Cup, ACDOA-264,Areta Multi-Drug Test Cup, ACDOA-6125B,Areta Multi-Drug Test Cup, ACDOA-754,BluRapids® MULTI-DRUG TEST CUP,CheckNow Multi - Drug Urine Test Cup,Clarity Multi-Drug Urine Test Cup (Urine),Drug Test Cup,easy@Home® Drug Test Cup,Easy@Home Drug Test Cup, ECDOA-1144A3,Easy@Home… |
|---|---|
| Owner/operator | Wondfo USA Co., Ltd. |
| Owner/operator number | 10028951 |
| Premarket submissions | K182701 |
| 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
- 100–999 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