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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device reagents for molecular diagnostic test systems
Definition Non-analyte-specific reagents used as part of molecular diagnostic test systems, such as polymerases, nucleotides and nucleotide mixes, master mixes in which individual reagents are optimized to be used together.
Product CodePFT
Regulation Number 862.3800
Device Class 1

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