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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 infection
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 quantifies the relative levels of host response proteins isolated from serum or similar specimens.
Product CodeQPS
Regulation Number 866.3215
Device Class 2


Premarket Reviews
ManufacturerDecision
DIASORIN, INC.
  SUBSTANTIALLY EQUIVALENT 1
MEMED DIAGNOSTICS, LTD.
  SUBSTANTIALLY EQUIVALENT 3

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