FDA product code QFS

Monocyte Distribution Width Quantitative Measurement For Sepsis Risk Assessment

Microbiology·Class 2·21 CFR 866.3215
US regulatory classifications
US Product Code (FDA)
QFS
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US Risk Class (FDA)
Class 2
US Regulation (CFR)
21 CFR 866.3215
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Medical specialty
Microbiology
Device characteristics
GMP exempt
No
Implantable
No
Life-sustaining
No
Third party review
Not Eligible
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.

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About this record

Monocyte Distribution Width Quantitative Measurement For Sepsis Risk Assessment is a medical device type in the Microbiology specialty. This page includes real-world medical device registration data worldwide for this device type, with registrations from US FDA, Brazil ANVISA, and other global markets.

View regulatory classifications, recent 510(k) clearances, active device registrations, and similar products registered globally under this device category. Pure Global AI's free directory provides comprehensive worldwide registration intelligence across 7,000+ medical device types and 21 specialties.