Monocyte Distribution Width Quantitative Measurement For Sepsis Risk Assessment
FDA product code QFS · Class II (moderate risk) · 21 CFR 866.3215 · Microbiology
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.
1510(k) clearances
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Manufacturers
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K181599 | Unicel DxH 800 Cellular Analysis System with Early Sepsis Indicator ApplicationQFS · Traditional | Beckman Coulter | 03/18/2019SE |