21 CFR 880.2900
§ 880.2900 Clinical color change thermometer.
United States · 21 CFR — Food and Drugs · Status: effective
Cite this
- Citation
- 21 CFR 880.2900, § 880.2900 Clinical color change thermometer, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/90509
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Full text
(a) Identification. A clinical color change thermometer is a disposable device used to measure a patient's oral, rectal, or axillary (armpit) body temperature. The device records body temperature by use of heat sensitive chemicals which are sealed at the end of a plastic or metal strip. Body heat causes a stable color change in the heat sensitive chemicals.
(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 § 880.9.
Legislative history
This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.