§ 866.2850. Automated zone reader.
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/us/cfr/t21/s§ 866.2850·A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
(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).