[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: 21CFR866.2480]

[Page 241]
 
                        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. 866.2480  Quality control kit for culture media.

    (a) Identification. A quality control kit for culture media is a 
device that consists of paper discs (or other suitable materials), each 
impregnated with a specified, freeze-dried, viable microorganism, 
intended for medical purposes to determine if a given culture medium is 
able to support the growth of that microorganism. The device aids in the 
diagnosis of disease caused by pathogenic microorganisms and also 
provides epidemiological information on these diseases.
    (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 25046, June 12, 1989; 66 
FR 38791, July 25, 2001]