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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 of sepsis
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 immunoassay that measures the relative levels of host response proteins isolated from host blood or similar specimens.
Product CodeSCX
Regulation Number 866.3215
Device Class 2


Premarket Reviews
ManufacturerDecision
ABIONIC SA
  SUBSTANTIALLY EQUIVALENT 1

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