[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2002]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR862.1140]

[Page 181-182]
 
                        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

[[Page 182]]

(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.