{"data":{"id":"us/21-cfr-862.3560","jurisdiction":"us","citation":"21 CFR 862.3560","heading":"Lithium test system.","body":"(a) Identification. A lithium test system is a device intended to measure lithium (from the drug lithium carbonate) in serum or plasma. Measurements of lithium are used to assure that the proper drug dosage is administered in the treatment of patients with mental disturbances, such as manic-depressive illness (bipolar disorder).\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":"73e06c8f163c0e0ca36d52163b63eb867cf83068cdc59dd7b56169908e78ad54","source_id":"us-cfr","stale":true,"prev":"us/21-cfr-862.3555","next":"us/21-cfr-862.3580"},"notice":"GroundRules: Original legal text. Not legal advice."}