21 CFR § 866.2540 - Microbiological incubator.

---
identifier: "/us/cfr/t21/s866.2540"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 866.2540 - Microbiological incubator."
title_number: 21
title_name: "Food and Drugs"
section_number: "866.2540"
section_name: "Microbiological incubator."
chapter_name: "FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES"
subchapter_number: "H"
subchapter_name: "MEDICAL DEVICES"
part_number: "866"
part_name: "IMMUNOLOGY AND MICROBIOLOGY DEVICES"
positive_law: false
currency: "2026-04-05"
last_updated: "2026-04-05"
format_version: "1.1.0"
generator: "[email protected]"
authority: "21 U.S.C. 351, 360, 360c, 360e, 360j, 360 371."
regulatory_source: "47 FR 50823, Nov. 9, 1982, unless otherwise noted."
cfr_part: "866"
---


# 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 management system regulation in part 820 of this chapter, except for requirements concerning records and complaint files under § 820.35 of this chapter.

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