{"data":{"id":"us/21-cfr-866.2580","jurisdiction":"us","citation":"21 CFR 866.2580","heading":"Gas-generating device.","body":"(a) Identification. A gas-generating device is a device intended for medical purposes that produces predetermined amounts of selected gases to be used in a closed chamber in order to establish suitable atmospheric conditions for cultivation of microorganisms with special atmospheric requirements. The device aids in the diagnosis of disease.\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":"8497b30a5ed1632932f116bacdfe2f639dada9072c905c2311ad4b774d7e04a8","source_id":"us-cfr","stale":true,"prev":"us/21-cfr-866.2560","next":"us/21-cfr-866.2600"},"notice":"GroundRules: Original legal text. Not legal advice."}