FDA device listing
Rapid Response Multi-Drug One Step Cup (Urine),Rapid Response Multi-Drug Test Cup,Rapid Response Multi-Drug Test Panel…
FDA device listing 1488190377 · BTNX Inc.
Key facts
| Proprietary names | Rapid Response Multi-Drug One Step Cup (Urine),Rapid Response Multi-Drug Test Cup,Rapid Response Multi-Drug Test Panel (Urine),Rapid Response One Step DOA Cup MOR 2000 (Urine),Rapid Response One Step DOA Cup MOR 300 (Urine),Rapid Response One Step DOA Test Cup (Urine),Rapid Response Single/Multi DOA Panel MOR 2000 (Urine),Rapid Response Single/Multi DOA Panel MOR 300 (Urine) |
|---|---|
| Owner/operator | BTNX Inc. |
| Owner/operator number | 9058575 |
| Premarket submissions | K180349 |
| Product codes | NFT, NFV, NFW, NFY, NGG, NGL, NGM, PTG, PTH, QAW, QBF |
| Device names | 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, NGM - Test, Phencyclidine (Pcp), 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.NGM |
| Review panels | Clinical Toxicology |
| Registered establishments | BTNX Inc. |
| Establishment registrations | 3003917514 |
| FEI numbers | 3003917514 |
| Establishment operations | Foreign Private Label Distributor, Repackager/Relabeler |
| 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