The US Food and Drug Administration (FDA) has granted 510(k) clearance to Nanosphere's CYP2C19 nucleic acid test to determine gene variants affecting drug metabolism. The CYP2C19 enzyme, in general, metabolizes approximately 15% of all ...
Tags: FDA, CYP2C19 enzyme, automated sample-to-result Verigene system
Nanosphere has obtained the US Food and Drug Administration's (FDA) 510(k) approval for its infectious C difficile test, designed for use on the sample-to-result Verigene system. By automating the steps of bacterial DNA extraction, ...
Tags: Nanosphere, difficile test, verigene system, health
The US Food and Drug Administration (FDA) has granted de novo petition to market Nanosphere's gram-positive blood culture nucleic acid test (BC-GP) on the automated sample-to-result Verigene system. Single automated BC-GP test detects ...
Tags: Nanosphere, FDA, BC-GP test, Verigene system