[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2008]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR866.2360]

[Page 257-258]
 
                        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

[[Page 258]]

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]