[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2002]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR866.1700]

[Page 237-238]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 866--IMMUNOLOGY AND MICROBIOLOGY DEVICES--Table of Contents
 
                      Subpart B--Diagnostic Devices
 
Sec. 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

[[Page 238]]

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).