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47 FR 50823, Nov. 9, 1982, unless otherwise noted.
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Subscribe to: 21 CFR 866.2850
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Nomenclature changes to part 866 appear at 73 FR 35341, June 23, 2008.
(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).