21 CFR § 862.1770 Clinical Chemistry and Clinical Toxicology Devices

§ 862.1770 Urea nitrogen test system.

Current through Sep 8, 2026 · Read all of Part 862

⚠ 2 pending changes to Part 862

(a) Identification. A urea nitrogen test system is a device intended to measure urea nitrogen (an end-product of nitrogen metabolism) in whole blood, serum, plasma, and urine. Measurements obtained by this device are used in the diagnosis and treatment of certain renal and metabolic diseases.

(b) Classification. Class II.

← § 862.1730 Free tyrosine test system.§ 862.1775 Uric acid test system. →