21 CFR Part 862 · Clinical Chemistry and Clinical Toxicology Devices
(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.
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Federal Register documents that created or amended this section.