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QLU — Anti-Factor Xa Activity Test System, Apixaban Class II

FDA Device Classification

Classification Details

Product Code
QLU
Device Class
Class II
Regulation Number
864.7295
Submission Type
Review Panel
HE
Medical Specialty
Hematology
Implant
No

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.

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K240315siemens healthcare diagnostics productsINNOVANCE Anti-Xa (OPPU05); INNOVANCE Apixaban Standards (OPPW05); INNOVANCE ApiOctober 10, 2024
K223187instrumentation laboratoryHemosIL Liquid Anti-XaJune 23, 2023
DEN190032instrumentation laboratoryHemosIL Liquid Anti-XaSeptember 17, 2020