DeviceClearance

Product code QFS— Microbiology

Unicel DxH 800 Cellular Analysis System with Early Sepsis Indicator Application

Classification name
Monocyte Distribution Width Quantitative Measurement For Sepsis Risk Assessment
Device class
Class 2
Regulation
21 CFR 866.3215
Advisory panel
Microbiology
Total cleared
1
First cleared
Most recent

FDA classification definition

“An elevated Monocyte Distribution Width (MDW) value, together with other laboratory findings and clinical information, aids in identifying patients with sepsis or at increased risk of developing sepsis following hospital admission. MDW should not be used as the sole basis to determine the absence of sepsis.”

— U.S. Food and Drug Administration, device classification record for product code QFS under 21 CFR 866.3215, via openFDA

Market context for product code QFS

FDA has cleared 1 device under product code QFS, all in 2019, 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.

Top applicants under product code QFS

Recent clearances under product code QFS

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