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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device immunoassay for host biomarkers to predict risk of 28-day all-cause mortality in patients with sepsis and septic shock.
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 immunoassay used to detect host biomarkers as an aid to assess the risk of 28-day all-cause mortality in patients with sepsis and septic shock.
Product CodeSJQ
Regulation Number 866.3215
Device Class 2


Premarket Reviews
ManufacturerDecision
B·R·A·H·M·S GMBH (PART OF THERMO FISHER SCIENTIFIC)
  SUBSTANTIALLY EQUIVALENT 1

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