{"data":{"id":"us/21-cfr-862.3035","jurisdiction":"us","citation":"21 CFR 862.3035","heading":"Amikacin test system.","body":"(a) Identification. An amikacin test system is a device intended to measure amikacin, an aminoglycoside antibiotic drug, in serum and plasma. Measurements obtained by this device are used in the diagnosis and treatment of amikacin overdose and in monitoring levels of amikacin 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":"b3c5f35f783ac0b59dcd209e8ac24cc5f130b50d560c8fb9422951aa1a356075","source_id":"us-cfr","stale":true,"prev":"us/21-cfr-862.3030","next":"us/21-cfr-862.3040"},"notice":"GroundRules: Original legal text. Not legal advice."}