[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2001]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR866.3085]

[Page 241]
 
                        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. 866.3085  Brucella spp. serological reagents.

    (a) Identification. Brucella spp. serological reagents are devices 
that consist of antigens and antisera used for serological 
identification of Brucella spp. from cultured isolates derived from 
clinical specimens or to identify antibodies to Brucella spp. in serum. 
Additionally, some of these reagents consist of antisera conjugated with 
a fluorescent dye (immunofluorescent reagents) used to identify Brucella 
spp. directly from clinical specimens or cultured isolates derived from 
clinical specimens. The identification aids in the diagnosis of 
brucellosis (e.g., undulant fever, Malta fever) caused by bacteria 
belonging to the genus Brucella and provides epidemiological information 
on diseases caused by these microorganisms.
    (b) Classification. Class II (special controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to Sec. 866.9.

[47 FR 50823, Nov. 9, 1982, as amended at 63 FR 59226, Nov. 3, 1998]