[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: 21CFR862.1205]

[Page 199]
 
                        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. 862.1205  Cortisol (hydrocortisone and hydroxycorticosterone)
test system.

    (a) Identification. A cortisol (hydrocortisone and 
hydroxycorticosterone) test system is a device intended to measure the 
cortisol hormones secreted by the adrenal gland in plasma and urine. 
Measurements of cortisol are used in the diagnosis and treatment of 
disorders of the adrenal gland.
    (b) Classification. Class II.