21 C.F.R. § 862.1770

Current through November 30, 2024
Section 862.1770 - Urea nitrogen test system
(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.

21 C.F.R. § 862.1770