FDA Product Code PCA: Dna Genetic Analyzer

A Genetic Analyzer Is An Automated Clinical Multiplex Instrument System Intended To Measure And Sort Signals Generated By Multiple Fluorescent Dyes In Order To Analyze Dna/rna Molecules In An Assay From A Clinical Sample. Individual Nucleotide Sequences And Dna Fragment Sizes Are Identified Using Chain- Or Dye-termination Or Dye Primer Cycle Sequencing, Or Pcr Amplification With Labeled Primers, Respectively. Labeled Nucleotides And Dna Fragments Are Separated By Size And Charge Using A Polymer-based Separation Matrix With Capillary Electrophoresis Or Other Method. Fluorescence Emissions Are Measured Using Filters On A Photodiode Or Other Detector And Interpreted With Software.