{"data":{"id":"us/21-cfr-866.5580","jurisdiction":"us","citation":"21 CFR 866.5580","heading":"Alpha-1-lipoprotein immunological test system.","body":"(a) Identification. An alpha-1-lipoprotein immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the alpha-1-lipoprotein (high-density lipoprotein) in serum and plasma. Measurement of alpha-1-lipoprotein may aid in the diagnosis of Tangier disease (a hereditary disorder of fat metabolism).\n(b) Classification. Class II (performance standards).","path":["Title 21—Food and Drugs","CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES","SUBCHAPTER H—MEDICAL DEVICES","PART 866—IMMUNOLOGY AND MICROBIOLOGY DEVICES","Subpart F—Immunological 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":"2927fac6ff176b2e0fc6e6d5cb2b35c7bba753129f2dda3d78cde40fb5c1cd5c","source_id":"us-cfr","stale":true,"prev":"us/21-cfr-866.5570","next":"us/21-cfr-866.5590"},"notice":"GroundRules: Original legal text. Not legal advice."}