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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device infliximab test system
Definition An infliximab test system intended for the measurement of an infliximab as an aid in the management of patients with Crohn’s disease or ulcerative colitis.
Product CodeQXT
Regulation Number 862.3115
Device Class 2


Premarket Reviews
ManufacturerDecision
PROCISEDX, INC.
  GRANTED 1

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