[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2002]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR862.1065]

[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. 862.1065  Ammonia test system.

    (a) Identification. An ammonia test system is a device intended to 
measure ammonia levels in blood, serum, and plasma, Ammonia measurements 
are used in the diagnosis and treatment of severe liver disorders, such 
as cirrhosis, hepatitis, and Reye's syndrome.
    (b) Classification. Class I.