{"data":{"id":"us/21-cfr-862.1110","jurisdiction":"us","citation":"21 CFR 862.1110","heading":"Bilirubin (total or direct) test system.","body":"(a) Identification. A bilirubin (total or direct) test system is a device intended to measure the levels of bilirubin (total or direct) in plasma or serum. Measurements of the levels of bilirubin, an organic compound formed during the normal and abnormal distruction of red blood cells, if used in the diagnosis and treatment of liver, hemolytic hematological, and metabolic disorders, including hepatitis and gall bladder block.\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":"f8da15e00ade6885f57b7b681be020ba2fbeae1ea8b62994e7d6474cce72dba4","source_id":"us-cfr","stale":true,"prev":"us/21-cfr-862.1100","next":"us/21-cfr-862.1113"},"notice":"GroundRules: Original legal text. Not legal advice."}