FDA Product Code NZB: Quality Control Material, Genetics, Dna

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.

Leading manufacturers include Maine Molecular Quality Controls, Inc., Gentris Corporation and Instrumentation Laboratory CO.