21 CFR 862.1770 - Urea nitrogen test system.

Regulations last checked for updates: May 07, 2025

Title 21 - Food and Drugs last revised: Apr 28, 2025

View all text of Subpart B [§ 862.1020 - § 862.1840]

§ 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.

authority: 21 U.S.C. 351,360,360c,360e,360j,360l,371

source: 52 FR 16122, May 1, 1987, unless otherwise noted.

cite as: 21 CFR 862.1770