Code of Federal Regulations · Section

§ 862.1035 — Albumin Test System

21 C.F.R. § 862.1035

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(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. § 862.1030 21 C.F.R. § 862.1040

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