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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
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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