[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: 21CFR862.1140]

[Page 188]
 
                        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. 862.1140  Calcitonin test system.

    (a) Identification. A calcitonin test system is a device intended to 
measure the thyroid hormone calcitonin (thyrocalcitonin) levels in 
plasma and serum. Calcitonin measurements are used in the diagnosis and 
treatment of diseases involving the thyroid and parathyroid glands, 
including carcinoma and hyperparathyroidism (excessive activity of the 
parathyroid gland).
    (b) Classification. Class II.