[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2005]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR862.1070]

[Page 201]
 
                        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.