[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2008]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR862.1225]

[Page 200]
 
                        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. 862.1225  Creatinine test system.

    (a) Identification. A creatinine test system is a device intended to 
measure creatinine levels in plasma and urine. Creatinine measurements 
are used in the diagnosis and treatment of renal diseases, in monitoring 
renal dialysis, and as a calculation basis for measuring other urine 
analytes.
    (b) Classification. Class II.