NZB

Quality Control Material, Genetics, Dna

Product code

NZB

Device name

Quality Control Material, Genetics, Dna

Device class

Class 2

21 CFR

21 CFR 866.5910

Medical specialty

Microbiology

Marketing pathway

510(K) Exempt

510(k) clearances (all years, FDA)

4 (all years; only the last 3 years are listed here)

FDA classification 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.

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