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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device dna and rna oncology controls
Definition Oncology controls are a device intended for use in a next generation sequencing (NGS)-based in vitro diagnostic test system as a quality control to monitor analytical performance of the library preparation, sequencing, and analysis steps of the workflow by detecting systematic analytical deviations that may arise from reagent or instrument variation. This type of device includes synthetic DNA and RNA controls.
Product CodeSCU
Regulation Number 866.5910
Device Class 2

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