QIG

Quality Control Material, Genetics, Rna

Product code

QIG

Device name

Quality Control Material, Genetics, Rna

Device class

Class 2

21 CFR

21 CFR 866.5910

Medical specialty

Microbiology

Marketing pathway

510(K) Exempt

FDA classification 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.

Definition text from the FDA device classification database (U.S. federal government work, public domain).