{"data":{"id":"us/21-cfr-866.5425","jurisdiction":"us","citation":"21 CFR 866.5425","heading":"Alpha-2-glycoproteins immunological test system.","body":"(a) Identification. An alpha-2-glycoproteins immunolgical test system is a device that consists of the reagents used to measure by immunochemical techniques the alpha-2-glycoproteins (a group of plasma proteins found in the alpha-2 group when subjected to electrophoresis) in serum and other body fluids. Measurement of alpha-2-glycoproteins aids in the diagnosis of some cancers and genetically inherited deficiencies of these plasma proteins.\n(b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 866.9.","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":"492f66d9ff3901bcd2f93c04ba60cded9a4fa243780bfe87f474e24e1db6d35b","source_id":"us-cfr","stale":true,"prev":"us/21-cfr-866.5420","next":"us/21-cfr-866.5430"},"notice":"GroundRules: Original legal text. Not legal advice."}