[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: 21CFR866.2360]

[Page 240]
 
                        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. 866.2360  Selective culture medium.

    (a) Identification. A selective culture medium is a device that 
consists primarily of liquid or solid biological materials intended for 
medical purposes to cultivate and identify certain pathogenic 
microorganisms. The device contains one or more components that suppress 
the growth of certain microorganisms while either promoting or not 
affecting the growth of other microorganisms. 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]