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Coagulation System For The Measurement Of Whole Blood Viscoelastic Properties

FDA product code QFR · 7 cleared devices

Class 2 Hematology
Regulation
21 CFR 864.5430
Review panel
HE
Implant
No
Life sustaining
No
Third party review
No
GMP exempt
No
Clearance span
2020-08-21 – 2025-08-25

A coagulation system for the measurement of whole blood viscoelastic properties is an in vitro diagnostic device used to evaluate blood coagulation, fibrinolysis, or both, in patients.

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