Code of Federal Regulations · Section

§ 862.1770 — Urea Nitrogen Test System

21 C.F.R. § 862.1770

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(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. § 862.1730 21 C.F.R. § 862.1775

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