21 C.F.R. · Food and Drugs
21 C.F.R. § 866.2850

Automated zone reader.

Title 21 C.F.R. ● ACTIVE Primary Source
Regulatory Text

21 C.F.R. § 866.2850 — Automated zone reader.

§ 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).

Source: ecfr.gov · govinfo.gov — public domain Official Source ↗
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21 C.F.R. § 866.2850
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The regulatory text of 21 C.F.R. § 866.2850 is reproduced from the official Code of Federal Regulations as published by the Office of the Federal Register and the National Archives and Records Administration.
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