FDA device listing
ACCU NEWS Drug Test Cup, Multi Drug 5 Urine Cup (THC-COC-MET-AMP-MOP),ACCU NEWS Multi-Drug Screen Test, Multi-Drug 5…
FDA device listing 1705116392 · Core Technology Co., Ltd.
Key facts
| Proprietary names | ACCU NEWS Drug Test Cup, Multi Drug 5 Urine Cup (THC-COC-MET-AMP-MOP),ACCU NEWS Multi-Drug Screen Test, Multi-Drug 5 Test Panel (THC-COC-MET-AMP-MOP),ACCU NEWS Single Drug Screen Test, COC Test,ACCU NEWS Single Drug Screen Test, THC Test,CorDx Drug Screening Test Card,CorDx Drug Screening Urine Cup,TyFast Drug Screening Urine Card,TyFast Drug Screening Urine Cup |
|---|---|
| Owner/operator | Core Technology Co., Ltd. |
| Owner/operator number | 10044021 |
| Product codes | DIO, DJC, DJG, DKZ, LDJ |
| Device names | DIO - Enzyme Immunoassay, Cocaine And Cocaine Metabolites, DJC - Thin Layer Chromatography, Methamphetamine, DJG - Enzyme Immunoassay, Opiates, DKZ - Enzyme Immunoassay, Amphetamine, LDJ - Enzyme Immunoassay, Cannabinoids |
| Device class | Class II |
| Classification regulations (21 CFR) | 862.3100, 862.3250, 862.3610, 862.3650, 862.3870 |
| Review panels | Clinical Toxicology |
| Registered establishments | CORE TECHNOLOGY CO., LTD. |
| Establishment registrations | 3008054239 |
| FEI numbers | 3008054239 |
| 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