---
kind: "section"
citation: "21 C.F.R. § 866.2540"
title: "21"
number: "866.2540"
heading: "Microbiological incubator."
url: "https://uscodex.org/cfr/21/866.2540"
---

# §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](/cfr/21/part807-subpartE.md) of this chapter subject to the limitations in [§ 866.9](/cfr/21/866.9.md). The device is also exempt from the good manufacturing practice requirements of the quality management system regulation in [part 820](/cfr/21/part820.md) of this chapter, except for requirements concerning records and complaint files under [§ 820.35](/cfr/21/820.35.md) of this chapter.

## Notes

### Amendments

[47 FR 50823, Nov. 9, 1982, as amended at 66 FR 38791, July 25, 2001; 90 FR 55982, Dec. 4, 2025]

### Authority

Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360 l, 371.

### Source

Source: 47 FR 50823, Nov. 9, 1982, unless otherwise noted.

### Amendments

[47 FR 50823, Nov. 9, 1982, as amended at 66 FR 38791, July 25, 2001; 90 FR 55982, Dec. 4, 2025]