FDA device listing
Enzyme Immunoassay, Cocaine And Cocaine Metabolites
FDA device listing 2019560102 · HEALGEN SCIENTIFIC LLC
Key facts
| Owner/operator | HEALGEN SCIENTIFIC LLC |
|---|---|
| Owner/operator number | 10038461 |
| Premarket submissions | K163704 |
| Product codes | DIO, DIS, DJG, DJR, DKZ, JXM, JXN, LAF, LCM, LDJ, LFG |
| Device names | DIO - Enzyme Immunoassay, Cocaine And Cocaine Metabolites, DIS - Enzyme Immunoassay, Barbiturate, DJG - Enzyme Immunoassay, Opiates, DJR - Enzyme Immunoassay, Methadone, DKZ - Enzyme Immunoassay, Amphetamine, JXM - Enzyme Immunoassay, Benzodiazepine, JXN - Enzyme Immunoassay, Propoxyphene, LAF - Gas Chromatography, Methamphetamine, LCM - Enzyme Immunoassay, Phencyclidine, LDJ - Enzyme Immunoassay, Cannabinoids, LFG - Radioimmunoassay, Tricyclic Antidepressant Drugs |
| 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.LCM |
| Review panels | Clinical Toxicology |
| Registered establishments | HEALGEN SCIENTIFIC LLC |
| Establishment registrations | 3009238284 |
| FEI numbers | 3009238284 |
| Establishment operations | Complaint File Establishment, Specification Developer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- None 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