[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: 21CFR862.1045]

[Page 194]
 
                        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. 862.1045  Aldosterone test system.

    (a) Identification. An aldosterone test system is a device intended 
to measure the hormone aldosterone in serum and urine. Aldosterone 
measurements are used in the diagnosis and treatment of primary 
aldosteronism (a disorder caused by the excessive secretion of 
aldosterone by the adrenal gland), hypertension caused by primary 
aldosteronism, selective hypoaldosteronism, edematous states, and other 
conditions of electrolyte imbalance.
    (b) Classification. Class II.