QFS

Monocyte Distribution Width Quantitative Measurement For Sepsis Risk Assessment

Product code

QFS

Device name

Monocyte Distribution Width Quantitative Measurement For Sepsis Risk Assessment

Device class

Class 2

21 CFR

21 CFR 866.3215

Medical specialty

Microbiology

Marketing pathway

510(K)

510(k) clearances (all years, FDA)

1 (all years; only the last 3 years are listed here)

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.

Definition text from the FDA device classification database (U.S. federal government work, public domain).