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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device oral fluid drugs of abuse and alcohol test specimen collection device
Regulation Description Blood specimen collection device.
Definition Intended for use in the collection, preservation, and transport of oral fluid specimens for drugs of abuse or alcohol testing.
Product CodePJD
Regulation Number 862.1675
Device Class 2


Premarket Reviews
ManufacturerDecision
EPITOME
  SUBSTANTIALLY EQUIVALENT 2
ORASURE TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 1

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