21 C.F.R. § 866.1700 Culture medium for antimicrobial susceptibility tests.
Title 21 - Food and Drugs
(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).
Title 21: Food and Drugs
PART 866—IMMUNOLOGY AND MICROBIOLOGY DEVICES
Subpart B—Diagnostic Devices
§ 866.1700 Culture medium for antimicrobial susceptibility tests.
