{"data":{"id":"us/21-cfr-866.2170","jurisdiction":"us","citation":"21 CFR 866.2170","heading":"Automated colony counter.","body":"(a) Identification. An automated colony counter is a mechanical device intended for medical purposes to determine the number of bacterial colonies present on a bacteriological culture medium contained in a petri plate. The number of colonies counted is used in the diagnosis of disease as a measure of the degree of bacterial infection.\n(b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 866.9.","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":"8b5783cc1ac8f22b6b28645f4afd957ec1bb74a09c4897d14fb6bf6cccfed48b","source_id":"us-cfr","stale":true,"prev":"us/21-cfr-866.2160","next":"us/21-cfr-866.2180"},"notice":"GroundRules: Original legal text. Not legal advice."}