Home › Device types › QLU
Anti-Factor Xa Activity Test System, Apixaban
FDA product code QLU · Class 2 · Hematology
8
Registered devices
0
Adverse events
1
Recalls
3
510(k) clearances
Devices with this code
HemosIL Liquid Anti-Xa — INSTRUMENTATION LABORATORY COMPANYINNOVANCE Apixaban Controls — Siemens Healthcare Diagnostics Products GmbHINNOVANCE Apixaban Standards — Siemens Healthcare Diagnostics Products GmbHINNOVANCE Apixaban Controls — Siemens Healthcare Diagnostics Products GmbHHemosIL Liquid Anti-Xa — INSTRUMENTATION LABORATORY COMPANYINNOVANCE Anti-Xa — Siemens Healthcare Diagnostics Products GmbHINNOVANCE Apixaban Standard — Siemens Healthcare Diagnostics Products GmbHINNOVANCE Anti-Xa — Siemens Healthcare Diagnostics Products GmbH
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2021-08-25 | Instrumentation Laboratory | Labeled On-board instrument stability issue for current and future lots, reduced On-board Instrument Stability from 7 days to 5 days |
Query this across every FDA database — by API.
Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.
Get your free API keyRead the docsSourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.
