[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: 21CFR866.2450]

[Page 258-259]
 
                        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. 866.2450  Supplement for culture media.

    (a) Identification. A supplement for culture media is a device, such 
as a vitamin or sugar mixture, that is added

[[Page 259]]

to a solid or liquid basal culture medium to produce a desired 
formulation and that is intended for medical purposes to enhance the 
growth of fastidious microorganisms (those having complex nutritional 
requirements). This device aids in the diagnosis of diseases caused by 
pathogenic microorganisms.
    (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]