[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: 21CFR862.1190]

[Page 182]
 
                        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. 862.1190  Copper test system.

    (a) Identification. A copper test system is a device intended to 
measure copper levels in plasma, serum, and urine. Measurements of 
copper are used in the diagnosis and treatment of anemia, infections, 
inflammations, and Wilson's disease (a hereditary disease primarily of 
the liver and nervous system). Test results are also used in monitoring 
patients with Hodgkin's disease (a disease primarily of the lymph 
system).
    (b) Classification. Class I. The device is exempt from the premarket 
notification procedures in subpart E of part 807.

[52 FR 16122, May 1, 1987, as amended at 53 FR 21449, June 8, 1988]