StacksVerified U.S. regulatory reference

21 CFR §862.1065

Verified against eCFR.gov as of June 20, 2026View official text on eCFR.gov
  1. (a)Identification. An ammonia test system is a device intended to measure ammonia levels in blood, serum, and plasma, Ammonia measurements are used in the diagnosis and treatment of severe liver disorders, such as cirrhosis, hepatitis, and Reye's syndrome.
  2. (b)Classification. Class I.