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Monocyte Distribution Width Quantitative Measurement For Sepsis Risk Assessment

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.

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Monocyte Distribution Width Quantitative Measurement For Sepsis Risk Assessment
Microbiology Medical Device Type
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Regulatory Classifications

US Regulatory Classifications

QFS

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Class 2

21 CFR 866.3215

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Microbiology

Device Characteristics

No

No

No

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.