{"data":{"id":"us/21-cfr-866.5160","jurisdiction":"us","citation":"21 CFR 866.5160","heading":"Beta-globulin immunological test system.","body":"(a) Identification. A beta-globulin immunological test system is a device that consists of reagents used to measure by immunochemical techniques beta globulins (serum protein) in serum and other body fluids. Beta-globulin proteins include beta-lipoprotein, transferrin, glycoproteins, and complement, and are rarely associated with specific pathologic disorders.\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":"b6a424ea68f36d7715a38c5782df2a8c1edbab5c189fa2ceeff2526fd441016b","source_id":"us-cfr","stale":true,"prev":"us/21-cfr-866.5150","next":"us/21-cfr-866.5170"},"notice":"GroundRules: Original legal text. Not legal advice."}