Text
Title 21: Food and Drugs
CHAPTER I: FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED)
SUBCHAPTER H: MEDICAL DEVICES
PART 862: CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES
Subpart B: Clinical Chemistry Test Systems
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.
Sponsored links
