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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device tissue rna preservative for collection, storage, and transportation
Definition The human tissue RNA preservation collection, storage, and transportation tube is a single-use, prefilled container intended for the collection, storage, and transportation of fresh human tissue specimens for subsequent RNA isolation and further molecular diagnostic testing.
Product CodeOZF
Regulation Number 866.4070
Device Class 2


Premarket Reviews
ManufacturerDecision
ASURAGEN, INC.
  SUBSTANTIALLY EQUIVALENT 1

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