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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device deformability cytometry 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 A semi-quantitative assay that measures cellular deformability and other physical properties of leukocytes in whole blood samples to aid the early detection of sepsis
Product CodeQUT
Regulation Number 866.3215
Device Class 2


Premarket Reviews
ManufacturerDecision
CYTOVALE, INC.
  SUBSTANTIALLY EQUIVALENT 3

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