Title 21

SECTION 862.1070

862.1070 Amylase test system.

§ 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.

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