21 C.F.R. § 866.2850

Current through October 31, 2024
Section 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).

21 C.F.R. §866.2850