{"data":{"id":"us/21-cfr-866.2850","jurisdiction":"us","citation":"21 CFR 866.2850","heading":"Automated zone reader.","body":"(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.\n(b) Classification. Class I (general controls).","path":["Title 21—Food and Drugs","CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES","SUBCHAPTER H—MEDICAL DEVICES","PART 866—IMMUNOLOGY AND MICROBIOLOGY DEVICES","Subpart C—Microbiology Devices"],"source_url":"https://www.ecfr.gov/api/versioner/v1/full/2026-08-25/title-21.xml","current_through":"2026-08-25","vintage":"","retrieved_at":"2026-08-27T02:24:47Z","sha256":"307f6ea31849118808a0c37b715f0e380ff7612574b3b7046d2a679ab549e91e","source_id":"us-cfr","stale":true,"prev":"us/21-cfr-866.2680","next":"us/21-cfr-866.2900"},"notice":"GroundRules: Original legal text. Not legal advice."}