[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2008]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR866.1700]

[Page 255]
 
                        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 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).

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