{"data":{"id":"us/21-cfr-862.1815","jurisdiction":"us","citation":"21 CFR 862.1815","heading":"Vitamin E test system.","body":"(a) Identification. A vitamin E test system is a device intended to measure vitamin E (tocopherol) in serum. Measurements obtained by this device are used in the diagnosis and treatment of infants with vitamin E deficiency syndrome.\n(b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 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":"7ed2ba5f6cd9999262f4c0bd1ab5b2a527a3203e060065878d37acb13e9c57e6","source_id":"us-cfr","stale":true,"prev":"us/21-cfr-862.1810","next":"us/21-cfr-862.1820"},"notice":"GroundRules: Original legal text. Not legal advice."}