FDA device listing
Benzodiazepines Direct ELISA Kit,Benzodiazepines Oral Fluid Enzyme Immunoassay,Zolpidem Direct ELISA Kit,Zolpidem Urine…
FDA device listing 1809196785 · ABBOTT LABORATORIES
Key facts
| Proprietary names | Benzodiazepines Direct ELISA Kit,Benzodiazepines Oral Fluid Enzyme Immunoassay,Zolpidem Direct ELISA Kit,Zolpidem Urine HEIA |
|---|---|
| Owner/operator | ABBOTT LABORATORIES |
| Owner/operator number | 1415939 |
| Product codes | JXM |
| Device names | JXM - Enzyme Immunoassay, Benzodiazepine |
| Device class | Class II |
| Classification regulations (21 CFR) | 862.3170 |
| Review panels | Clinical Toxicology |
| Registered establishments | Alere San Diego, Inc. |
| Establishment registrations | 2020952 |
| FEI numbers | 2020952 |
| Establishment operations | U.S. Manufacturer of Export Only Devices |
| 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