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Anti-Factor Xa Activity Test System, Apixaban

FDA product code QLU · 2 cleared devices

Class 2 Hematology
Regulation
21 CFR 864.7295
Review panel
HE
Implant
No
Life sustaining
No
Third party review
No
GMP exempt
No
Clearance span
2023-06-23 – 2024-10-10

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.

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