eCFR Reference Browser

---

title: "21 CFR §866.1640"

source: "https://www.ecfr.gov/current/title-21/section-866.1640"

title_number: "21"

volume_number: "8"

chapter_number: "Unknown"

subchapter_code: "H"

subchapter_subject: "MEDICAL DEVICES"

part_code: "866"

part_subject: "IMMUNOLOGY AND MICROBIOLOGY DEVICES"

subpart_code: "B"

subpart_subject: "Diagnostic Devices"

section_number: "866.1640"

section_subject: "Antimicrobial susceptibility test powder."

cfr_reference: "21 CFR 866.1640"

title_name: "Title 21"

title_subject: "Food and Drugs"

parts_covered: "Parts 800 to 1299"

revised_date: "Revised as of April 1, 2019"

publication_date: "As of April 1, 2019"

contains_description: "Containing a codification of documents of general applicability and future effect"

publication_info: "Published by the Office of the Federal Register National Archives and Records Administration as a Special Edition of the Federal Register"

---

(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).

§866.1640 - Antimicrobial susceptibility test powder.