FDA device listing
ACRO Multi-Drug Screen Cup,ACRO Multi-Drug Screen Cup for Home use,AllTest Multi-Drug Rapid Urine Test Cup,AllTest…
FDA device listing 2063504245 · Hangzhou AllTest Biotech Co.,Ltd
Key facts
| Proprietary names | ACRO Multi-Drug Screen Cup,ACRO Multi-Drug Screen Cup for Home use,AllTest Multi-Drug Rapid Urine Test Cup,AllTest Multi-Drug Urine Test Cup,Atida Multiplex Drug of Abuse Rapid Urine Cup Test,Atida Multiplex Drug of Abuse Urine Cup Test,CHOSEN Multi-Drug Rapid Urine Test Cup,CHOSEN Multi-Drug Urine Test Cup,Citest Multi-Drug Urine Cup,Citest Multi-Drug Urine Test Cup,CLIAwaived,Inc. Complete Drug… |
|---|---|
| Owner/operator | Hangzhou AllTest Biotech Co.,Ltd |
| Owner/operator number | 10050156 |
| Premarket submissions | K250727 |
| 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 | Hangzhou AllTest Biotech Co.,Ltd |
| Establishment registrations | 3012073813, 3027519599, 3043127647 |
| FEI numbers | 3012073813, 3027519599, 3043127647 |
| Establishment operations | Manufacturer |
| 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