Coagulation System For The Measurement Of Whole Blood Viscoelastic Properties
Medical specialty
Hematology
Device class
2
Regulation number
864.5430
Review panel
HE
Implant
N
Life sustaining/supporting
N
GMP exempt
N
Third party review
N
Summary malfunction reporting
Ineligible
Definition
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.