DeviceClearance

Product code QLU— Hematology

HemosIL Liquid Anti-Xa

Classification name
Anti-Factor Xa Activity Test System, Apixaban
Device class
Class 2
Regulation
21 CFR 864.7295
Advisory panel
Hematology
Total cleared
3
First cleared
Most recent

FDA classification 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.”

— U.S. Food and Drug Administration, device classification record for product code QLU under 21 CFR 864.7295, via openFDA

Market context for product code QLU

FDA has cleared 3 devices under product code QLU between 2020 and 2024, filed by 2 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

Top applicants under product code QLU

Recent clearances under product code QLU

Data sourced from openFDA. This site is unofficial and independent of the FDA.