# Monocyte Distribution Width Quantitative Measurement For Sepsis Risk Assessment
> **Product code: QFS** · Class II — Moderate Risk (510(k) clearance required) · Microbiology · 21 CFR 866.3215
## Classification
- **FDA Product Code:** QFS
- **Device class:** Class II — Moderate Risk (510(k) clearance required)
- **Regulation:** 21 CFR 866.3215
- **Review panel:** MI
- **Medical specialty:** Microbiology
- **Submission type:** 1
- **GMP exempt:** N
- **Life sustaining:** N
- **Implant:** N
- **Third-party review:** N
## 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.

## Market data
- **Cleared 510(k) submissions:** 1
- **Registered establishments:** 2
## Source
- [FDA Device Classification](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/classification.cfm?ID=QFS)
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