[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: 21CFR866.2900]

[Page 250]
 
                        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. 866.2900  Microbiological specimen collection and transport device.

    (a) Identification. A microbiological specimen collection and 
transport device is a specimen collecting chamber intended for medical 
purposes to preserve the viability or integrity of microorganisms in 
specimens during storage of specimens after their collection and during 
their transport from the collecting area to the laboratory. The device 
may be labeled or otherwise represented as sterile. The device aids in 
the diagnosis of disease caused by pathogenic microorganisms.
    (b) Classification. Class I (general controls).