{"data":{"id":"us/21-cfr-862.3450","jurisdiction":"us","citation":"21 CFR 862.3450","heading":"Gentamicin test system.","body":"(a) Identification. A gentamicin test system is a device intended to measure gentamicin, an antibiotic drug, in human specimens. Measurements obtained by this device are used in the diagnosis and treatment of gentamicin overdose and in monitoring levels of gentamicin to ensure appropriate therapy.\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 D—Clinical Toxicology 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":"763df51290ac62577de20cd1e583fe2dad16b6394307592a3fa5950a2e8082a5","source_id":"us-cfr","stale":true,"prev":"us/21-cfr-862.3380","next":"us/21-cfr-862.3460"},"notice":"GroundRules: Original legal text. Not legal advice."}