21 CFR § 862.1070 Clinical Chemistry and Clinical Toxicology Devices

§ 862.1070 Amylase test system.

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

⚠ 2 pending changes to Part 862

(a) Identification. An amylase test system is a device intended to measure the activity of the enzyme amylase in serum and urine. Amylase measurements are used primarily for the diagnosis and treatment of pancreatitis (inflammation of the pancreas).

(b) Classification. Class II.

← § 862.1065 Ammonia test system.§ 862.1075 Androstenedione test system. →