DeviceClearance

Product code QFR— Hematology

QStat Cartridge

Classification name
Coagulation System For The Measurement Of Whole Blood Viscoelastic Properties
Device class
Class 2
Regulation
21 CFR 864.5430
Advisory panel
Hematology
Total cleared
8
First cleared
Most recent

FDA classification 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.”

— U.S. Food and Drug Administration, device classification record for product code QFR under 21 CFR 864.5430, via openFDA

Market context for product code QFR

FDA has cleared 8 devices under product code QFR between 2019 and 2025, filed by 1 applicant company. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

Top applicants under product code QFR

Recent clearances under product code QFR

Data sourced from openFDA. This site is unofficial and independent of the FDA.