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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device quality control material, genetics, dna
Regulation Description Quality control material for cystic fibrosis nucleic acid assays.
Definition Dna quality control material for genetic testing is a device intended for medical purposes for use in a test system to estimate test precision and to detect systematic analytical deviations that may arise from reagent or analytical instrument variation. This type of device includes synthetic dna controls and cell-line based controls.
Product CodeNZB
Regulation Number 866.5910
Device Class 2

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