FDA device listing
ARK Apixaban Assay,ARK Apixaban Calibrator,ARK Apixaban Control
FDA device listing 1217158091 · ARK Diagnostics Inc
Key facts
| Proprietary names | ARK Apixaban Assay,ARK Apixaban Calibrator,ARK Apixaban Control |
|---|---|
| Owner/operator | ARK Diagnostics Inc |
| Owner/operator number | 10027663 |
| Product codes | QLU |
| Device names | QLU - Anti-Factor Xa Activity Test System, Apixaban |
| Device class | Class II |
| Classification regulations (21 CFR) | 864.7295 |
| Review panels | Hematology |
| Registered establishments | ARK DIAGNOSTICS INC |
| Establishment registrations | 3005755244 |
| FEI numbers | 3005755244 |
| 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