[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: 21CFR862.1145]

[Page 197]
 
                        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. 862.1145  Calcium test system.

    (a) Identification. A calcium test system is a device intended to 
measure the total calcium level in serum. Calcium measurements are used 
in the diagnosis and treatment of parathyroid disease, a variety of bone 
diseases, chronic renal disease and tetany (intermittent muscular 
contractions or spasms).
    (b) Classification. Class II.