part_subject: "IMMUNOLOGY AND MICROBIOLOGY DEVICES"
subpart_code: "B"
subpart_subject: "Diagnostic Devices"
section_number: "866.1700"
section_subject: "Culture medium for antimicrobial susceptibility tests."
cfr_reference: "21 CFR 866.1700"
title_name: "Title 21"
title_subject: "Food and Drugs"
parts_covered: "Parts 800 to 1299"
revised_date: "Revised as of April 1, 2019"
publication_date: "As of April 1, 2019"
contains_description: "Containing a codification of documents of general applicability and future effect"
publication_info: "Published by the Office of the Federal Register National Archives and Records Administration as a Special Edition of the Federal Register"
---
(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).