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Code · CFR · Title 21 — Food and Drugs · Part 866 — Immunology and Microbiology Devices · § 866.1640

§ 866.1640. Antimicrobial susceptibility test powder.

65 words·~1 min read·/us/cfr/t21/s§ 866.1640·

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(a)Identification. An antimicrobial susceptibility test powder is a device that consists of an antimicrobial drug powder packaged in vials in specified amounts and intended for use in clinical laboratories for determining in vitro susceptibility of bacterial pathogens to these therapeutic agents. Test results are used to determine the antimicrobial agent of choice in the treatment of bacterial diseases.
(b)Classification. Class II (performance standards).
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