Code of Federal Regulations · Section

§ 862.1070 — Amylase Test System

21 C.F.R. § 862.1070

View:

(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. § 862.1065 21 C.F.R. § 862.1075

Authorizing Statute