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

MDR Year MDR Reports MDR Events
2025 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Low Test Results 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 1 1

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