QLU
3 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Anti-Factor Xa Activity Test System, Apixaban
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 864.7295
- Medical specialty
- Hematology
- FDA definition
- A heparin and direct oral factor Xa inhibitor drug test system is intended for the detection of heparin and direct oral factor Xa inhibitors in human specimens collected from patients taking heparin or direct oral factor Xa inhibitors. This device is intended to aid in the management of therapy in conjunction with other clinical and laboratory findings.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| INNOVANCE Anti-Xa (OPPU05); INNOVANCE Apixaban Standards (OPPW05); INNOVANCE Apixaban Controls (OPPS05) (K240315) | Siemens Healthcare Diagnostics Products GmbH | 2024-10-10 |
| HemosIL Liquid Anti-Xa (K223187) | Instrumentation Laboratory CO | 2023-06-23 |
| HemosIL Liquid Anti-Xa (DEN190032) | Instrumentation Laboratory CO | 2020-09-17 |
Track QLU automatically
Every clearance here is in the API, with alerts when new ones post.