FDA Product Code LON: System, Test, Automated, Antimicrobial Susceptibility, Short Incubation

Under FDA product code LON, automated antimicrobial susceptibility testing systems are cleared for use in clinical microbiology laboratories.

Unlike manual methods, LON systems automatically inoculate, incubate, and read antimicrobial susceptibility panels, delivering results in hours rather than days. They are essential in high-volume laboratories requiring rapid, standardized antibiotic susceptibility data.

LON devices are Class II medical devices, regulated under 21 CFR 866.1645 and reviewed by the FDA Microbiology panel.

Leading manufacturers include bioMerieux, Inc., Becton, Dickinson & CO and Dade Behring, Inc..