21 CFR 866.2170
§ 866.2170 Automated colony counter.
United States · 21 CFR — Food and Drugs · Status: effective
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- Citation
- 21 CFR 866.2170, § 866.2170 Automated colony counter, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/89449
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Full text
(a) Identification. An automated colony counter is a mechanical device intended for medical purposes to determine the number of bacterial colonies present on a bacteriological culture medium contained in a petri plate. The number of colonies counted is used in the diagnosis of disease as a measure of the degree of bacterial infection.
(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.
Legislative history
This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.