{"data":{"id":"us/21-cfr-862.1145","jurisdiction":"us","citation":"21 CFR 862.1145","heading":"Calcium test system.","body":"(a) Identification. A calcium test system is a device intended to measure the total calcium level in serum. Calcium measurements are used in the diagnosis and treatment of parathyroid disease, a variety of bone diseases, chronic renal disease and tetany (intermittent muscular contractions or spasms).\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":"41e5f8815f8226f05661ce028a74e3ac29c5b360a3672d108e8fa6f27c0c1fc4","source_id":"us-cfr","stale":true,"prev":"us/21-cfr-862.1140","next":"us/21-cfr-862.1150"},"notice":"GroundRules: Original legal text. Not legal advice."}