{"data":{"id":"us/21-cfr-866.5430","jurisdiction":"us","citation":"21 CFR 866.5430","heading":"Beta-2-glycoprotein I immunological test system.","body":"(a) Identification. A beta-2-glycoprotein I immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the beta-2-glycoprotein I (a serum protein) in serum and other body fluids. Measurement of beta-2-glycoprotein I aids in the diagnosis of an inherited deficiency of this serum protein.\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":"4af888dfd7276935388cd34066c29a218ce83787f0273e72abdff3f974a66573","source_id":"us-cfr","stale":true,"prev":"us/21-cfr-866.5425","next":"us/21-cfr-866.5440"},"notice":"GroundRules: Original legal text. Not legal advice."}