FDA product code QLU

Anti-Factor Xa Activity Test System, Apixaban

Hematology·Class 2·21 CFR 864.7295
US regulatory classifications
US Product Code (FDA)
QLU
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US Risk Class (FDA)
Class 2
US Regulation (CFR)
21 CFR 864.7295
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Medical specialty
Hematology
Device characteristics
GMP exempt
No
Implantable
No
Life-sustaining
No
Third party review
Not Eligible
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.

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About this record

Anti-Factor Xa Activity Test System, Apixaban is a medical device type in the Hematology specialty. This page includes real-world medical device registration data worldwide for this device type, with registrations from US FDA, Brazil ANVISA, and other global markets.

View regulatory classifications, recent 510(k) clearances, active device registrations, and similar products registered globally under this device category. Pure Global AI's free directory provides comprehensive worldwide registration intelligence across 7,000+ medical device types and 21 specialties.