{"data":{"id":"us/21-cfr-862.1360","jurisdiction":"us","citation":"21 CFR 862.1360","heading":"Gamma-glutamyl transpeptidase and isoenzymes test system.","body":"(a) Identification. A gamma-glutamyl transpeptidase and isoenzymes test system is a device intended to measure the activity of the enzyme gamma-glutamyl transpeptidase (GGTP) in plasma and serum. Gamma-glutamyl transpeptidase and isoenzymes measurements are used in the diagnosis and treatment of liver diseases such as alcoholic cirrhosis and primary and secondary liver tumors.\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":"7ade3e6b0a4b48c560ff6a384d7f7b3b7b055e65eb131730424d58a615a788ae","source_id":"us-cfr","stale":true,"prev":"us/21-cfr-862.1358","next":"us/21-cfr-862.1365"},"notice":"GroundRules: Original legal text. Not legal advice."}