[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: 21CFR866.2390]

[Page 237]
 
                        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. 866.2390  Transport culture medium.

    (a) Identification. A transport culture medium is a device that 
consists of a semisolid, usually non-nutrient, medium that maintains the 
viability of suspected pathogens contained in patient specimens while in 
transit from the specimen collection area to the laboratory. 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).

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