{"data":{"id":"us/21-cfr-862.1640","jurisdiction":"us","citation":"21 CFR 862.1640","heading":"Protein-bound iodine test system.","body":"(a) Identification. A protein-bound iodine test system is a device intended to measure protein-bound iodine in serum. Measurements of protein-bound iodine obtained by this device are used in the diagnosis and treatment of thyroid disorders.\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 the limitations in § 862.9.","path":["Title 21—Food and Drugs","CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES","SUBCHAPTER H—MEDICAL DEVICES","PART 862—CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES","Subpart B—Clinical Chemistry 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":"648675c2abf981b5cd7d11a8ab19026f0e78d85ce550f27b52c6cad096636439","source_id":"us-cfr","stale":true,"prev":"us/21-cfr-862.1635","next":"us/21-cfr-862.1645"},"notice":"GroundRules: Original legal text. Not legal advice."}