21 C.F.R. § 862.1035 – Albumin test system. | Midpage
§ 862.1035
21 C.F.R. § 862.1035
Albumin test system.
(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.