[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2001]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR862.1090]

[Page 179]
 
                        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 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.