{"data":{"id":"us/21-cfr-862.1825","jurisdiction":"us","citation":"21 CFR 862.1825","heading":"Vitamin D test system.","body":"(a) Identification. A vitamin D test system is a device intended for use in clinical laboratories for the quantitative determination of 25-hydroxyvitamin D (25-OH-D) and other hydroxylated metabolites of vitamin D in serum or plasma to be used in the assessment of vitamin D sufficiency.\n(b) Classification. Class II (special controls). Vitamin D test systems must comply with the following special controls:\n(1) Labeling in conformance with 21 CFR 809.10 and\n(2) Compliance with existing standards of the National Committee on Clinical Laboratory Standards.","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":"14e9cb012160d02e142198eba663542cb031e133a801c8e881099d35d8b9fd57","source_id":"us-cfr","stale":true,"prev":"us/21-cfr-862.1820","next":"us/21-cfr-862.1840"},"notice":"GroundRules: Original legal text. Not legal advice."}