FDA device listing
Alinity c Serum Benzodiazepines Reagent Kit,DRI Benzodiazepine Serum Tox Assay,Multigent Serum Benzodiazepines,Siemens…
FDA device listing 1022988260 · Thermo Fisher Scientific
Key facts
| Proprietary names | Alinity c Serum Benzodiazepines Reagent Kit,DRI Benzodiazepine Serum Tox Assay,Multigent Serum Benzodiazepines,Siemens ADVIA® Chemistry Serum Benzodiazepine |
|---|---|
| Owner/operator | Thermo Fisher Scientific |
| Owner/operator number | 2517925 |
| Premarket submissions | K960708 |
| 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 | Microgenics Corporation |
| Establishment registrations | 3010939897 |
| FEI numbers | 3010939897 |
| Establishment operations | Contract Manufacturer, 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