QFS

1 FDA 510(k) clearances · Product code

FDA profile

Official device name

Monocyte Distribution Width Quantitative Measurement For Sepsis Risk Assessment

Device class

Class II (moderate risk)

Regulation

21 CFR 866.3215

Medical specialty

Microbiology

FDA 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.

Download CSV table Client report (share link) ◉ Watch

Both buttons carry the same predicate table: the CSV downloads for your worksheet, the report is a shareable page for clients. Exports: 3 free/month with an account · reports & watching free.

Building a predicate table? Click + Add on candidates below (up to 8), then compare and export from your Builder.