Current through October 31, 2024
Section 866.2850 - Automated zone reader(a)Identification. An automated zone reader is a mechanical device intended for medical purposes to measure zone diameters of microbial growth inhibition (or exhibition), such as those observed on the surface of certain culture media used in disc-agar diffusion antimicrobial susceptibility tests. The device aids in decisionmaking respecting the treatment of disease.(b)Classification. Class I (general controls).