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Monocyte Distribution Width Quantitative Measurement For Sepsis Risk Assessment

FDA product code QFS · 1 cleared devices

Class 2 Microbiology
Regulation
21 CFR 866.3215
Review panel
MI
Implant
No
Life sustaining
No
Third party review
No
GMP exempt
No
Clearance span
2019-03-18 – 2019-03-18

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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