[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: 21CFR866.3110]

[Page 262]
 
                        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. 866.3110  Campylobacter fetus serological reagents.

    (a) Identification. Campylobacter fetus serological reagents are 
devices that consist of antisera conjugated with a fluorescent dye used 
to identify Campylobacter fetus from clinical specimens or cultured 
isolates derived from clinical specimens. The identification aids in the 
diagnosis of diseases caused by this bacterium and provides 
epidemiological information on these diseases. Campylobacter fetus is a 
frequent cause of abortion in sheep and cattle and is sometimes 
responsible for endocarditis (inflammation of certain membranes of the 
heart) and enteritis (inflammation of the intestines) in humans.
    (b) Classification. Class I (general controls).