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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device system, blood collection, rna stabilization, rna purification, rt-pcr molecular diagnostic test
Regulation Description RNA Preanalytical Systems.
Definition System for collection, storage, and transport of whole blood and stabilization of intracellular rna with subsequent isolation and purification of host rna for rt-pcr used in molecular diagnostic testing
Product CodeNTW
Regulation Number 866.4070
Device Class 2