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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 A kit that is a set of reagents and consumables used in the processing of human genomic DNA samples derived from peripheral whole blood, and in the subsequent targeted re-sequencing of the resulting sample libraries. User-supplied analyte specific reagents are required for the preparation of libraries targeting specific genomic regions of interest. The kit is intended for use as part of molecular diagnostic test systems.
Product CodePFT
Regulation Number 862.3800
Device Class 1

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