QLU

Anti-Factor Xa Activity Test System, Apixaban

Product code

QLU

Device name

Anti-Factor Xa Activity Test System, Apixaban

Device class

Class 2

21 CFR

21 CFR 864.7295

Medical specialty

Hematology

Marketing pathway

510(K)

510(k) clearances (last 3 years)

1

Summaries archived here

1 (direct download)

510(k) clearances (all years, FDA)

3 (all years; only the last 3 years are listed here)

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.

Definition text from the FDA device classification database (U.S. federal government work, public domain).

510(k) clearances, last 3 years (1)

Last three years. Most recent: 2024-10-10.

1 summaries are archived here for direct download.