21 CFR 866.1645
§ 866.1645 Fully automated short-term incubation cycle antimicrobial susceptibility system.
United States · 21 CFR — Food and Drugs · Status: effective
Cite this
- Citation
- 21 CFR 866.1645, § 866.1645 Fully automated short-term incubation cycle antimicrobial susceptibility system, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/89441
- Permanent ID
ys:prov:89441@1- SHA-256
0f25c355c69930709695456f9046b012db64bcc85602cc4c22022bae68f78dea
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Full text
(a) Identification. A fully automated short-term incubation cycle antimicrobial susceptibility system is a device that incorporates concentrations of antimicrobial agents into a system for the purpose of determining in vitro susceptibility of bacterial pathogens isolated from clinical specimens. Test results obtained from short-term (less than 16 hours) incubation are used to determine the antimicrobial agent of choice to treat bacterial diseases.
(b) Classification. Class II (special controls). The special control for this device is FDA's guidance document entitled “Class II Special Controls Guidance Document: Antimicrobial Susceptibility Test (AST) Systems; Guidance for Industry and FDA.”
Legislative history
This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.