§ 862.1035. Albumin test system.
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/us/cfr/t21/s§ 862.1035·A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
(a)Identification. An albumin test system is a device intended to measure the albumin concentration in serum and plasma. Albumin measurements are used in the diagnosis and treatment of numerous diseases involving primarily the liver or kidneys.
(b)Classification. Class II.