[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2008]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR866.2540]

[Page 259]
 
                        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. 866.2540  Microbiological incubator.

    (a) Identification. A microbiological incubator is a device with 
various chambers or water-filled compartments in which controlled 
environmental conditions, particularly temperature, are maintained. It 
is intended for medical purposes to cultivate microorganisms and aid in 
the diagnosis of disease.
    (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. The device is 
also exempt from the good manufacturing practice regulations in part 820 
of this chapter, with the exception of Sec. 820.180, with respect to 
general requirements concerning records, and Sec. 820.198, with respect 
to complaint files.

[47 FR 50823, Nov. 9, 1982, as amended at 66 FR 38791, July 25, 2001]