[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: 21CFR862.1230]

[Page 191]
 
                        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. 862.1230  Cyclic AMP test system.

    (a) Identification. A cyclic AMP test system is a device intended to 
measure the level of adenosine 3', 5'-monophosphate (cyclic AMP) in 
plasma, urine, and other body fluids. Cyclic AMP measurements are used 
in the diagnosis and treatment of endocrine disorders, including 
hyperparathyroidism (overactivity of the parathyroid gland). Cyclic AMP 
measurements may also be used in the diagnosis and treatment of Graves' 
disease (a disorder of the thyroid) and in the differentiation of causes 
of hypercalcemia (elevated levels of serum calcium.)
    (b) Classification. Class II.