[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: 21CFR862.1160]

[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. 862.1160  Bicarbonate/carbon dioxide test system.

    (a) Identification. A bicarbonate/carbon dioxide test system is a 
device intended to measure bicarbonate/carbon dioxide in plasma, serum, 
and whole blood. Bicarbonate/carbon dioxide measurements are used in the 
diagnosis and treatment of numerous potentially serious disorders 
associated with changes in body acid-base balance.
    (b) Classification. Class II.