[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: 21CFR862.1170]

[Page 189]
 
                        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. 862.1170  Chloride test system.

    (a) Identification. A chloride test system is a device intended to 
measure the level of chloride in plasma, serum, sweat, and urine. 
Chloride measurements are used in the diagnosis and treatment of 
electrolyte and metabolic disorders such as cystic fibrosis and diabetic 
acidosis.
    (b) Classification. Class II.