[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: 21CFR866.2850]

[Page 242]
 
                        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 C--Microbiology Devices
 
Sec. 866.2850  Automated zone reader.

    (a) Identification. An automated zone reader is a mechanical device 
intended for medical purposes to measure zone diameters of microbial 
growth inhibition (or exhibition), such as those observed on the surface 
of certain culture media used in disc-agar diffusion antimicrobial 
susceptibility tests. The device aids in decisionmaking respecting the 
treatment of disease.
    (b) Classification. Class I (general controls).