[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2001]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR862.1025]

[Page 177]
 
                        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. 862.1025  Adrenocorticotropic hormone (ACTH) test system.

    (a) Identification. An adrenocorticotropic hormone (ACTH) test 
system is a device intended to measure adrenocorticotropic hormone in 
plasma and serum. ACTH measurements are used in the differential 
diagnosis and treatment of certain disorders of the adrenal glands such 
as Cushing's syndrome, adrenocortical insufficiency, and the ectopic 
ACTH syndrome.
    (b) Classification. Class II.