21 CFR § 866.1700 Immunology and Microbiology Devices

§ 866.1700 Culture medium for antimicrobial susceptibility tests.

Current through Sep 8, 2026 · Read all of Part 866

(a) Identification. A culture medium for antimicrobial susceptibility tests is a device intended for medical purposes that consists of any medium capable of supporting the growth of many of the bacterial pathogens that are subject to antimicrobial susceptibility tests. The medium should be free of components known to be antagonistic to the common agents for which susceptibility tests are performed in the treatment of disease.

(b) Classification. Class II (performance standards).

← § 866.1655 System for detection of microorganisms and antimicrobial resistance using reporter expression.§ 866.2050 Staphylococcal typing bacteriophage. →