[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: 21CFR862.1120]

[Page 188]
 
                        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. 862.1120  Blood gases (PCO2, PO2) and blood pH test system.

    (a) Identification. A blood gases (PCO2, PO2) 
and blood pH test system is a device intended to measure certain gases 
in blood, serum, plasma or pH of blood, serum, and plasma. Measurements 
of blood gases (PCO2, PO2) and blood pH are used 
in the diagnosis and treatment of life-threatening acid-base 
disturbances.
    (b) Classification. Class II.