[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: 21CFR866.3065]

[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. 866.3065  Bordetella spp. serological reagents.

    (a) Identification. Bordetella spp. serological reagents are devices 
that consist of antigens and antisera, including antisera conjugated 
with a fluorescent dye, used in serological tests to identify Bordetella 
spp. from cultured isolates or directly from clinical specimens. The 
identification aids in the diagnosis of diseases caused by bacteria 
belonging to the genus Bordetella and provides epidemiological 
information on these diseases. Bordetella spp. cause whooping cough 
(Bordetella pertussis) and other similiarly contagious and acute 
respiratory infections characterized by pneumonitis (inflammation of the 
lungs).
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to the limitations in Sec. 866.9.

[47 FR 50823, Nov. 9, 1982, as amended at 54 FR 25046, June 12, 1989; 66 
FR 38791, July 25, 2001]