[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2001]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR866.2450]

[Page 238]
 
                        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 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. The device is exempt from the premarket 
notification procedures in subpart E of part 807 of this chapter.

[47 FR 50823, Nov. 9, 1982, as amended at 54 FR 25046, June 12, 1989]