FDA device listing
DOA Urine Cup,Multi-Drug Urine Test Panel
FDA device listing 1987348882 · Innovation Scientific Pty Ltd
Key facts
| Proprietary names | DOA Urine Cup,Multi-Drug Urine Test Panel |
|---|---|
| Owner/operator | Innovation Scientific Pty Ltd |
| Owner/operator number | 10093347 |
| 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 | INNOVATION SCIENTIFIC PTY LTD |
| Establishment registrations | 3031697086 |
| FEI numbers | 3031697086 |
| Establishment operations | Contract Manufacturer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- None listed 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