QFS · Class II · 21 CFR 866.3215

FDA Product Code QFS: Monocyte Distribution Width Quantitative Measurement For Sepsis Risk Assessment

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.

1
Total
1
Cleared
273d
Avg days
2019
Since

FDA 510(k) Cleared Monocyte Distribution Width Quantitative Measurement For Sepsis Risk Assessment Devices (Product Code QFS)

1 devices
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About Product Code QFS - Regulatory Context