[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR862.1070]

[Page 186]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 862--CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES--Table of Contents
 
               Subpart B--Clinical Chemistry Test Systems
 
Sec. 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.