Anti-factor Xa Activity Test System, Apixaban
Hematology · 21 CFR 864.7295
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.
Recent MDR events
0 adverse event reports on file
No MDR events on file for this product code.
Event type breakdown
No data available.
Most-reported manufacturers
No data available.
Recalls
1 recall events for this product code
Registered firms
7 firms currently registered for this product code
510(k) clearances
3 clearances for this product code
- Siemens Healthcare Diagnostics Products GmbHOct 10, 2024
K240315 · INNOVANCE Anti-Xa (OPPU05); INNOVANCE Apixaban Standards (OPPW05); INNOVANCE Apixaban Controls (OPPS05)
- Instrumentation Laboratory COJun 23, 2023
K223187 · HemosIL Liquid Anti-Xa
- Instrumentation Laboratory COSep 17, 2020
DEN190032 · HemosIL Liquid Anti-Xa