QLU · Class II — Moderate Risk (510(k) clearance required) · Hematology · 21 CFR 864.7295
Classification
FDA Product Code
QLU
Device class
Class II — Moderate Risk (510(k) clearance required)
Regulation
21 CFR 864.7295
Review panel
HE
Medical specialty
Hematology
Submission type
1
GMP exempt
N
Life sustaining
N
Implant
N
Third-party review
N
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.