{"data":{"id":"us/21-cfr-866.5620","jurisdiction":"us","citation":"21 CFR 866.5620","heading":"Alpha-2-macroglobulin immunological test system.","body":"(a) Identification. An alpha-2-macroglobulin immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the alpha-2-macroglobulin (a serum protein) in plasma. Measurement of alpha-2-macroglobulin may aid in the diagnosis of blood-clotting or clot lysis disorders.\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":"023a62156bc6c834c65ad92d95866ede94fb57c0648374b25c87f8d65a30df2b","source_id":"us-cfr","stale":true,"prev":"us/21-cfr-866.5600","next":"us/21-cfr-866.5630"},"notice":"GroundRules: Original legal text. Not legal advice."}