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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device device to detect and measure procalcitonin (pct) in human clinical specimens
Definition An assay used to determine the level of procalcitonin (PCT) in human serum and plasma as an aid in assessing the mortality for patients diagnosed with severe sepsis or septic shock.
Product CodePMT
Regulation Number 866.3215
Device Class 2


Premarket Reviews
ManufacturerDecision
BIOMERIEUX
  SUBSTANTIALLY EQUIVALENT 1
ROCHE DIAGNOSTICS CORP.
  SUBSTANTIALLY EQUIVALENT 1

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