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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device assay to measure pct to aid in the risk assessment of critically ill patients on their first day of icu admission
Definition Assay to measure procalcitonin to aid in the risk assessment of critically ill patients on their first day of ICU admission for progression to severe sepsis and septic shock
Product CodePTF
Regulation Number 866.3215
Device Class 2


Premarket Reviews
ManufacturerDecision
BECKMAN COULTER, INC
  SUBSTANTIALLY EQUIVALENT 1
BECKMAN COULTER, INC.
  SUBSTANTIALLY EQUIVALENT 1
DIAZYME LABORATORIES
  SUBSTANTIALLY EQUIVALENT 1

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