{"data":{"id":"us/21-cfr-866.5400","jurisdiction":"us","citation":"21 CFR 866.5400","heading":"Alpha-globulin immunological test system.","body":"(a) Identification. An alpha-globulin immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the alpha-globulin (a serum protein) in serum and other body fluids. Measurement of alpha-globulin may aid in the diagnosis of inflammatory lesions, infections, severe burns, and a variety of other conditions.\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":"c3c85a95e756d7340e0fa5fcd4ed3fa99c1160d2e1ad3487285151bbda7ad64c","source_id":"us-cfr","stale":true,"prev":"us/21-cfr-866.5380","next":"us/21-cfr-866.5420"},"notice":"GroundRules: Original legal text. Not legal advice."}