{"data":{"id":"us/21-cfr-862.1160","jurisdiction":"us","citation":"21 CFR 862.1160","heading":"Bicarbonate/carbon dioxide test system.","body":"(a) Identification. A bicarbonate/carbon dioxide test system is a device intended to measure bicarbonate/carbon dioxide in plasma, serum, and whole blood. Bicarbonate/carbon dioxide measurements are used in the diagnosis and treatment of numerous potentially serious disorders associated with changes in body acid-base balance.\n(b) Classification. Class II.","path":["Title 21—Food and Drugs","CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES","SUBCHAPTER H—MEDICAL DEVICES","PART 862—CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES","Subpart B—Clinical Chemistry Test Systems"],"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":"44d5df4201d67e4c2b0eec76ac5dffd920acdadbfb332b97db5537a03fddfafc","source_id":"us-cfr","stale":true,"prev":"us/21-cfr-862.1155","next":"us/21-cfr-862.1163"},"notice":"GroundRules: Original legal text. Not legal advice."}