21 C.F.R. § 862.1070

Current through October 31, 2024
Section 862.1070 - Amylase test system
(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.

21 C.F.R. § 862.1070