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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device antigen, inflammatory response marker, sepsis
Regulation Description Endotoxin assay.
Definition An immunoluminometric assay used to determine the concentration of procalcitonin (pct) in human serum and plasma.
Product CodeNTM
Regulation Number 866.3210
Device Class 2


Premarket Reviews
ManufacturerDecision
BIOMERIEUX
  SUBSTANTIALLY EQUIVALENT - CLIA SUBMISSION 1

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