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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device substance, blood grouping of non-human origin for in vitro diagnostic use
Regulation Description Blood group substances of nonhuman origin for in vitro diagnostic use.
Product CodeKSX
Regulation Number 864.9160
Device Class 2


Premarket Reviews
ManufacturerDecision
GAMMA
  SUBSTANTIALLY EQUIVALENT 2

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