{"data":{"id":"us/21-cfr-862.3680","jurisdiction":"us","citation":"21 CFR 862.3680","heading":"Primidone test system.","body":"(a) Identification. A primidone test system is a device intended to measure primidone, an antiepileptic drug, in human specimens. Measurements obtained by this device are used in the diagnosis and treatment of primidone overdose and in monitoring levels of primidone 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":"ea105d99352995fad3943ddd34686a61e8216966a70fdd20004a26e0e0aa2c83","source_id":"us-cfr","stale":true,"prev":"us/21-cfr-862.3670","next":"us/21-cfr-862.3700"},"notice":"GroundRules: Original legal text. Not legal advice."}