Product code QLU

Device name

Anti-Factor Xa Activity Test System, Apixaban

Medical specialty

Hematology

Device class

2

Regulation number

864.7295

Review panel

HE

Implant

N

Life sustaining/supporting

N

GMP exempt

N

Third party review

N

Summary malfunction reporting

Ineligible

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.

Source

FDA openFDA device classification dataset