[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: 21CFR866.2580]

[Page 239]
 
                        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. 866.2580  Gas-generating device.

    (a) Identification. A gas-generating device is a device intended for 
medical purposes that produces predetermined amounts of selected gases 
to be used in a closed chamber in order to establish suitable 
atmospheric conditions for cultivation of microorganisms with special 
atmospheric requirements. The device aids in the diagnosis of disease.
    (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]