Code of Federal Regulations (Last Updated: July 5, 2024) |
Title 21 - Food and Drugs |
Chapter I - Food and Drug Administration, Department of Health and Human Services |
SubChapter H - Medical Devices |
Part 866 - Immunology and Microbiology Devices |
Subpart C - Microbiology Devices |
§ 866.2540 - Microbiological incubator.
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§ 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]