NZB · Class II · 21 CFR 866.5910

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 Instrumentation Laboratory CO.

4
Total
3
Cleared
80d
Avg days
2006
Since