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Title 21: Food and Drugs
CHAPTER I: FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED)
SUBCHAPTER H: MEDICAL DEVICES
PART 866: IMMUNOLOGY AND MICROBIOLOGY DEVICES
Subpart C: Microbiology Devices
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 ? 866.9. The device is also exempt from the good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, with the exception of ? 820.180, with respect to general requirements concerning records, and ? 820.198, with respect to complaint files.
[47 FR 50823, Nov. 9, 1982, as amended at 66 FR 38791, July 25, 2001]
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