FDA device listing
Alinity c Benzodiazepines Qual Calibrator Kit,Alinity c Benzodiazepines Semiquant Calibrator Kit,Alinity c DOA MC…
FDA device listing 1393415212 · Thermo Fisher Scientific
Key facts
| Proprietary names | Alinity c Benzodiazepines Qual Calibrator Kit,Alinity c Benzodiazepines Semiquant Calibrator Kit,Alinity c DOA MC Negative Calibrator Kit,Alinity c DOA MC Qual Calibrator 2 Kit,Alinity c DOA MC Qual Low Calibrator 1 Kit,Alinity c DOA MC Semiquant Calibrator Kit,Alinity c TDM Multiconstituent Calibrator Kit,Alinity c Tox Qual Calibrators,Alinity c Tox Semiquant Calibrators,CEDIA Antibiotic TDM… |
|---|---|
| Owner/operator | Thermo Fisher Scientific |
| Owner/operator number | 2517925 |
| Product codes | DKB |
| Device names | DKB - Calibrators, Drug Mixture |
| Device class | Class II |
| Classification regulations (21 CFR) | 862.3200 |
| 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
- 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