{"data":{"id":"us/21-cfr-866.5420","jurisdiction":"us","citation":"21 CFR 866.5420","heading":"Alpha-1-glycoproteins immunological test system.","body":"(a) Identification. An alpha-1-glycoproteins immunological test system is a device that consists of the reagents used to measure by immunochemical techniques alpha-1-glycoproteins (a group of plasma proteins found in the alpha-1 group when subjected to electrophoresis) in serum and other body fluids. Measurement of specific alpha-1-glycoproteins may aid in the diagnosis of collagen (connective tissue) disorders, tuberculosis, infections, extensive malignancy, and diabetes.\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":"adacd1c48c55efbe6bd5ec70bd88bc45e2b167f6705b2388f427d30c9aeddad1","source_id":"us-cfr","stale":true,"prev":"us/21-cfr-866.5400","next":"us/21-cfr-866.5425"},"notice":"GroundRules: Original legal text. Not legal advice."}