FDA device listing
Biotronix Healthcare Cocaine Urine Test,Biotronix Healthcare Marijuana Urine Test
FDA device listing 1332878458 · Biotronix Healthcare Industries Inc.
Key facts
| Proprietary names | Biotronix Healthcare Cocaine Urine Test,Biotronix Healthcare Marijuana Urine Test |
|---|---|
| Owner/operator | Biotronix Healthcare Industries Inc. |
| Owner/operator number | 10043487 |
| Premarket submissions | K131754 |
| Product codes | DIO, LDJ |
| Device names | DIO - Enzyme Immunoassay, Cocaine And Cocaine Metabolites, LDJ - Enzyme Immunoassay, Cannabinoids |
| Device class | Class II |
| Classification regulations (21 CFR) | 862.3250, 862.3870 |
| Review panels | Clinical Toxicology |
| Registered establishments | BIOTRONIX HEALTHCARE INDUSTRIES INC. |
| Establishment registrations | 3010131137 |
| FEI numbers | 3010131137 |
| 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