eCFR Reference Browser

---

title: "21 CFR §866.2850"

source: "https://www.ecfr.gov/current/title-21/section-866.2850"

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: "C"

subpart_subject: "Microbiology Devices"

section_number: "866.2850"

section_subject: "Automated zone reader."

cfr_reference: "21 CFR 866.2850"

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 automated zone reader is a mechanical device intended for medical purposes to measure zone diameters of microbial growth inhibition (or exhibition), such as those observed on the surface of certain culture media used in disc-agar diffusion antimicrobial susceptibility tests. The device aids in decisionmaking respecting the treatment of disease.

(b)Classification. Class I (general controls).

§866.2850 - Automated zone reader.