QLU · Class II · 21 CFR 864.7295

FDA Product Code QLU: Anti-factor Xa Activity Test System, Apixaban

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.

Leading manufacturers include Instrumentation Laboratory CO.

2
Total
1
Cleared
352d
Avg days
2020
Since

List of Anti-factor Xa Activity Test System, Apixaban devices cleared through 510(k)

2 devices
1–2 of 2
Cleared Jun 23, 2023
HemosIL Liquid Anti-Xa
K223187
Instrumentation Laboratory CO
Hematology · 254d
Not Cleared Sep 17, 2020
HemosIL Liquid Anti-Xa
DEN190032
Instrumentation Laboratory CO
Hematology · 450d

How to use this database

This page lists all FDA 510(k) submissions for Anti-factor Xa Activity Test System, Apixaban devices (product code QLU). Click any device to view full submission details, including the decision date, manufacturer information, predicate device, and a link to the official FDA record.

These devices fall under the Hematology FDA review panel. Browse all Hematology devices →