Title 21

SECTION 862.1770

862.1770 Urea nitrogen test system.

§ 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.

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