[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR866.2320]

[Page 246-247]
 
                        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. 866.2320  Differential culture medium.

    (a) Identification. A differential culture medium is a device that 
consists primarily of liquid biological materials intended for medical 
purposes to cultivate and identify different types of pathogenic 
microorganisms. The identification of these microorganisms is 
accomplished by the addition of a specific biochemical component(s) to 
the medium. Microorganisms are identified by a visible change (e.g., a 
color change) in a specific biochemical component(s) which indicates 
that specific metabolic reactions have occurred. Test results aid in the 
diagnosis of disease and also provide epidemiological

[[Page 247]]

information on diseases caused by these 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 38790, July 25, 2001]