[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: 21CFR866.2330]

[Page 257]
 
                        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. 866.2330  Enriched culture medium.

    (a) Identification. An enriched culture medium is a device that 
consists primarily of liquid or solid biological materials intended for 
medical purposes to cultivate and identify fastidious microorganisms 
(those having complex nutritional requirements). The device consists of 
a relatively simple basal medium enriched by the addition of such 
nutritional components as blood, blood serum, vitamins, and extracts of 
plant or animal tissues. The device is used 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]