[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: 21CFR809.3]

[Page 84]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 809--IN VITRO DIAGNOSTIC PRODUCTS FOR HUMAN USE--Table of Contents
 
                      Subpart A--General Provisions
 
Sec. 809.3  Definitions.


    (a) In vitro diagnostic products are those reagents, instruments, 
and systems intended for use in the diagnosis of disease or other 
conditions, including a determination of the state of health, in order 
to cure, mitigate, treat, or prevent disease or its sequelae. Such 
products are intended for use in the collection, preparation, and 
examination of specimens taken from the human body. These products are 
devices as defined in section 201(h) of the Federal Food, Drug, and 
Cosmetic Act (the act), and may also be biological products subject to 
section 351 of the Public Health Service Act.
    (b) A product class is all those products intended for use for a 
particular determination or for a related group of determinations or 
products with common or related characteristics or those intended for 
common or related uses. A class may be further divided into subclasses 
when appropriate.
    (c) [Reserved]
    (d) Act means the Federal Food, Drug, and Cosmetic Act.

[41 FR 6903, Feb. 13, 1976, as amended at 45 FR 7484, Feb. 1, 1980]