FDA device listing
HINDERING Multi-Drug Rapid Test Cup,HINDERING Multi-Drug Rapid Test Cup Rx,HINDERING Multi-Drug Rapid Test…
FDA device listing 1392683125 · Hangzhou Tongzhou Biotechnology Co., Ltd
Key facts
| Proprietary names | HINDERING Multi-Drug Rapid Test Cup,HINDERING Multi-Drug Rapid Test Cup Rx,HINDERING Multi-Drug Rapid Test Panel,HINDERING Multi-Drug Rapid Test Panel Rx,TZcheck Multi-Drug Rapid Test Cup,TZcheck Multi-Drug Rapid Test Cup Rx,TZcheck Multi-Drug Rapid Test Panel,TZcheck Multi-Drug Rapid Test Panel Rx |
|---|---|
| Owner/operator | Hangzhou Tongzhou Biotechnology Co., Ltd |
| Owner/operator number | 10084418 |
| Premarket submissions | K233019 |
| Product codes | DIO, DIS, DJC, DJG, DJR, DKZ, DNK, JXM, LAF, LCM, LDJ, LFG and 11 more |
| Device names | DIO - Enzyme Immunoassay, Cocaine And Cocaine Metabolites, DIS - Enzyme Immunoassay, Barbiturate, DJC - Thin Layer Chromatography, Methamphetamine, DJG - Enzyme Immunoassay, Opiates, DJR - Enzyme Immunoassay, Methadone, DKZ - Enzyme Immunoassay, Amphetamine, DNK - Thin Layer Chromatography, Morphine, JXM - Enzyme Immunoassay, Benzodiazepine, LAF - Gas Chromatography, Methamphetamine, LCM - Enzyme Immunoassay, Phencyclidine, LDJ - Enzyme Immunoassay, Cannabinoids, LFG - Radioimmunoassay, Tricyclic Antidepressant Drugs and 11 more |
| Device class | Class II, Unclassified |
| Classification regulations (21 CFR) | 862.3100, 862.3150, 862.3170, 862.3250, 862.3610, 862.3620, 862.3640, 862.3650, 862.3870, 862.3910, ORCA1.LCM, ORCA1.NGM |
| Review panels | Clinical Toxicology |
| Registered establishments | HANGZHOU TONGZHOU BIOTECHNOLOGY CO., LTD |
| Establishment registrations | 3021986677 |
| FEI numbers | 3021986677 |
| Establishment operations | Repackager/Relabeler |
| 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