FDA device listing
Enzyme Immunoassay, Cocaine And Cocaine Metabolites
FDA device listing 1909377450 · Hangzhou Biotest Biotech Co.,Ltd.
Key facts
| Owner/operator | Hangzhou Biotest Biotech Co.,Ltd. |
|---|---|
| Owner/operator number | 10048622 |
| Product codes | DIO, DJC, DJG, DJR, DKZ, LCM, LDJ |
| Device names | DIO - Enzyme Immunoassay, Cocaine And Cocaine Metabolites, DJC - Thin Layer Chromatography, Methamphetamine, DJG - Enzyme Immunoassay, Opiates, DJR - Enzyme Immunoassay, Methadone, DKZ - Enzyme Immunoassay, Amphetamine, LCM - Enzyme Immunoassay, Phencyclidine, LDJ - Enzyme Immunoassay, Cannabinoids |
| Device class | Class II, Unclassified |
| Classification regulations (21 CFR) | 862.3100, 862.3250, 862.3610, 862.3620, 862.3650, 862.3870, ORCA1.LCM |
| Review panels | Clinical Toxicology |
| Registered establishments | Hangzhou Biotest Biotech Co.,Ltd. |
| Establishment registrations | 3011522054 |
| FEI numbers | 3011522054 |
| 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