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 and Company and BIOMERIEUX.
289
Total
289
Cleared
90d
Avg days
1986
Since
289 devices
Cleared
Aug 30, 2021
VITEK 2 AST-Gram Negative Piperacillin / Tazobactam (<=4 - =>128 µg/mL)
bioMerieux, Inc.
Microbiology
95d
Cleared
Jul 09, 2021
VITEK 2 AST-Gram Negative Meropenem (<= 0.25 - >=16 µg/mL)
bioMerieux, Inc.
Microbiology
385d
Cleared
Jun 14, 2021
VITEK 2 AST-Gram Negative Imipenem/Relebactam (<0.25/4 - >16/4 ug/ML)
bioMerieux, Inc.
Microbiology
59d