[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: 21CFR862.1090]

[Page 186-187]
 
                        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. 862.1090  Angiotensin converting enzyme (A.C.E.) test system.

    (a) Identification. An angiotensin converting enzyme (A.C.E.) test 
system is a device intended to measure the activity of angiotensin 
converting enzyme

[[Page 187]]

in serum and plasma. Measurements obtained by this device are used in 
the diagnosis and treatment of diseases such as sarcoidosis, a disease 
characterized by the formation of nodules in the lungs, bones, and skin, 
and Gaucher's disease, a hereditary disorder affecting the spleen.
    (b) Classification. Class II.