{"data":{"id":"us/21-cfr-866.5630","jurisdiction":"us","citation":"21 CFR 866.5630","heading":"Beta-2-microglobulin immunological test system.","body":"(a) Identification. A beta-2-microglobulin immunological test system is a device that consists of the reagents used to measure by immunochemical techniques beta-2-microglobulin (a protein molecule) in serum, urine, and other body fluids. Measurement of beta-2-microglobulin aids in the diagnosis of active rheumatoid arthritis and kidney disease.\n(b) Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 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":"fabcb9c754d28773ffbc093ff1ad005545dad66eec98a70ef8229db610c6fddf","source_id":"us-cfr","stale":true,"prev":"us/21-cfr-866.5620","next":"us/21-cfr-866.5640"},"notice":"GroundRules: Original legal text. Not legal advice."}