[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: 21CFR866.3120]

[Page 252]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 866--IMMUNOLOGY AND MICROBIOLOGY DEVICES--Table of Contents
 
                     Subpart D--Serological Reagents
 
Sec. 866.3120  Chlamydia serological reagents.

    (a) Identification. Chlamydia serological reagents are devices that 
consist of antigens and antisera used in serological tests to identify 
antibodies to chlamydia in serum. Additionally, some of these reagents 
consist of chlamydia antisera conjugated with a fluorescent dye used to 
identify chlamydia directly from clinical specimens or cultured isolates 
derived from clinical specimens. The identification aids in the 
diagnosis of disease caused by bacteria belonging to the genus Chlamydia 
and provides epidemiological information on these diseases. Chlamydia 
are the causative agents of psittacosis (a form of pneumonia), 
lymphogranuloma venereum (a venereal disease), and trachoma (a chronic 
disease of the eye and eyelid).
    (b) Classification. Class I (general controls).