21 C.F.R. § 862.1070 – Amylase test system. | Midpage
§ 862.1070
21 C.F.R. § 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).