FDA Product Code JWY: Manual Antimicrobial Susceptibility Test Systems

FDA product code JWY covers manual antimicrobial susceptibility test systems.

These diagnostic systems are used to determine which antibiotics are effective against specific bacterial or fungal isolates from patient samples. Results guide clinicians in selecting appropriate antibiotic therapy, a critical step in managing infections and combating antimicrobial resistance.

JWY devices are Class II medical devices, regulated under 21 CFR 866.1640 and reviewed by the FDA Microbiology panel.

Leading manufacturers include Thermo Fisher Scientific, Liofilchem S. R. L. and Beckman Coulter, Inc..