[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR866.1640]

[Page 245]
 
                        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. 866.1640  Antimicrobial susceptibility test powder.

    (a) Identification. An antimicrobial susceptibility test powder is a 
device that consists of an antimicrobial drug powder packaged in vials 
in specified amounts and intended for use in clinical laboratories for 
determining in vitro susceptibility of bacterial pathogens to these 
therapeutic agents. Test results are used to determine the antimicrobial 
agent of choice in the treatment of bacterial diseases.
    (b) Classification. Class II (performance standards).