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Electronic Code of Federal Regulations

e-CFR data is current as of February 13, 2020

Title 21Chapter ISubchapter HPart 866Subpart C → §866.2850


Title 21: Food and Drugs
PART 866—IMMUNOLOGY AND MICROBIOLOGY DEVICES
Subpart C—Microbiology Devices


§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).

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