FDA device listing
Amphetamine Urine Calibrator 1000,Amphetamine Urine Calibrator 500,Amphetamine Urine Calibrator Set,Amphetamine Urine…
FDA device listing 1337306454 · ABBOTT LABORATORIES
Key facts
| Proprietary names | Amphetamine Urine Calibrator 1000,Amphetamine Urine Calibrator 500,Amphetamine Urine Calibrator Set,Amphetamine Urine Control Set 1000,Amphetamine Urine Control Set 500,Amphetamine Urine HEIA Kit 100,Amphetamine Urine HEIA Kit 25,Amphetamine Urine HEIA Kit 500,Amphetamine Urine HEIA Olympus Wedge Kit 60 |
|---|---|
| Owner/operator | ABBOTT LABORATORIES |
| Owner/operator number | 1415939 |
| Premarket submissions | K143500 |
| Product codes | DKZ, DLJ, LAS |
| Device names | DKZ - Enzyme Immunoassay, Amphetamine, DLJ - Calibrators, Drug Specific, LAS - Drug Specific Control Materials |
| Device class | Class I, Class II |
| Classification regulations (21 CFR) | 862.3100, 862.3200, 862.3280 |
| Review panels | Clinical Toxicology |
| Registered establishments | Alere San Diego, Inc. |
| Establishment registrations | 2020952 |
| FEI numbers | 2020952 |
| Establishment operations | Manufacturer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- 1–9 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