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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device monocyte distribution width quantitative measurement for sepsis risk assessment
Regulation Description Device to detect and measure non-microbial analyte(s) in human clinical specimens to aid in assessment of patients with suspected sepsis.
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.
Product CodeQFS
Regulation Number 866.3215
Device Class 2

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