21 C.F.R. § 862.1035

Current through October 31, 2024
Section 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.
(b)Classification. Class II.

21 C.F.R. § 862.1035