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Code · CFR · Title 21 — Food and Drugs · Part 862 — Clinical Chemistry and Clinical Toxicology Devices · § 862.1770

§ 862.1770. Urea nitrogen test system.

49 words·~1 min read·/us/cfr/t21/s§ 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.
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