Product code QIG

Device name
Quality Control Material, Genetics, Rna
Medical specialty
Microbiology
Device class
2
Regulation number
866.5910
Review panel
MG
Implant
N
Life sustaining/supporting
N
GMP exempt
N
Third party review
N
Summary malfunction reporting
Ineligible
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.
Source
FDA openFDA device classification dataset