21 CFR § 862.1035 Clinical Chemistry and Clinical Toxicology Devices

§ 862.1035 Albumin test system.

Current through Sep 8, 2026 · Read all of Part 862

⚠ 2 pending changes to Part 862

(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.

← § 862.1030 Alanine amino transferase (ALT/SGPT) test system.§ 862.1040 Aldolase test system. →