[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: 21CFR866.2540]

[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. 866.2540  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). This device is 
exempt from premarket notification procedures in subpart E of part 807. 
The device also is exempt from the good manufacturing practice 
regulation in part 820 with the exception of Sec. 820.180, with respect 
to general requirements concerning records, and Sec. 820.198, with 
respect to complaint files.