{"data":{"id":"us/21-cfr-862.1510","jurisdiction":"us","citation":"21 CFR 862.1510","heading":"Nitrite (nonquantitative) test system.","body":"(a) Identification. A nitrite (nonquantitative) test system is a device intended to identify nitrite in urine. Nitrite identification is used in the diagnosis and treatment of uninary tract infection of bacterial origin.\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 § 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":"2d1d2765cd8832c011296f8b68a01053acb3399ca83db9f23475600b80854f96","source_id":"us-cfr","stale":true,"prev":"us/21-cfr-862.1509","next":"us/21-cfr-862.1515"},"notice":"GroundRules: Original legal text. Not legal advice."}