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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device blood detection capsule
Definition Ingestible gastrointestinal blood detection capsule device is a prescription device that uses spectrophotometry (light absorption technology) to detect the presence or absence of blood in the gastrointestinal tract.
Product CodeQUD
Regulation Number 876.1390
Device Class 2


Premarket Reviews
ManufacturerDecision
ENTERASENSE LTD.
  GRANTED 1

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