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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
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 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
DIASYS DIAGNOSTIC SYSTEMS GMBH
  SUBSTANTIALLY EQUIVALENT 1

Recalls
Manufacturer Recall Class Date Posted
1 Beckman Coulter Inc. II Feb-05-2025
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