21 CFR § 866.1700 - Culture medium for antimicrobial susceptibility tests.

---
identifier: "/us/cfr/t21/s866.1700"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 866.1700 - Culture medium for antimicrobial susceptibility tests."
title_number: 21
title_name: "Food and Drugs"
section_number: "866.1700"
section_name: "Culture medium for antimicrobial susceptibility tests."
chapter_name: "FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES"
subchapter_number: "H"
subchapter_name: "MEDICAL DEVICES"
part_number: "866"
part_name: "IMMUNOLOGY AND MICROBIOLOGY DEVICES"
positive_law: false
currency: "2026-04-05"
last_updated: "2026-04-05"
format_version: "1.1.0"
generator: "[email protected]"
authority: "21 U.S.C. 351, 360, 360c, 360e, 360j, 360 371."
regulatory_source: "47 FR 50823, Nov. 9, 1982, unless otherwise noted."
cfr_part: "866"
---


# 866.1700 Culture medium for antimicrobial susceptibility tests.

(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).