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Code of Federal Regulations Title 21. Food and Drugs § 21.866.2850 Automated zone reader

Current as of January 02, 2025 | Updated by Findlaw Staff

(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).

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Cite this article: FindLaw.com - Code of Federal Regulations Title 21. Food and Drugs § 21.866.2850 Automated zone reader - last updated January 02, 2025 | https://codes.findlaw.com/cfr/title-21-food-and-drugs/cfr-sect-21-866-2850/

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