(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]