[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2005]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR866.2170]

[Page 261-262]
 
                        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. 866.2170  Automated colony counter.

    (a) Identification. An automated colony counter is a mechanical 
device intended for medical purposes to determine the number of 
bacterial colonies

[[Page 262]]

present on a bacteriological culture medium contained in a petri plate. 
The number of colonies counted is used in the diagnosis of disease as a 
measure of the degree of bacterial infection.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to the limitations in Sec. 866.9.

[47 FR 50823, Nov. 9, 1982, as amended at 54 FR 25045, June 12, 1989; 66 
FR 38790, July 25, 2001]