FDA device listing
HemosIL Apixaban Controls,HemosIL Dabigatran Controls,HemosIL Rivaroxaban Controls
FDA device listing 1392639118 · Instrumentation Laboratory Co.
Key facts
| Proprietary names | HemosIL Apixaban Controls,HemosIL Dabigatran Controls,HemosIL Rivaroxaban Controls |
|---|---|
| Owner/operator | Instrumentation Laboratory Co. |
| Owner/operator number | 1217183 |
| Product codes | LAS |
| Device names | LAS - Drug Specific Control Materials |
| Device class | Class I |
| Classification regulations (21 CFR) | 862.3280 |
| Review panels | Clinical Toxicology |
| Registered establishments | INSTRUMENTATION LABORATORY CO., INSTRUMENTATION LABORATORY CO. - Devens |
| Establishment registrations | 2431530, 3037000637 |
| FEI numbers | 2431530, 3037000637 |
| 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