[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2005]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR866.3140]

[Page 268-269]
 
                        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. 866.3140  Corynebacterium spp. serological reagents.

    (a) Identification. Corynebacterium spp. serological reagents are 
devices that consist of antisera conjugated with a fluorescent dye used 
to identify Corynebacterium spp. from clinical specimens. The 
identification aids in the diagnosis of disease caused by bacteria 
belonging to the genus Corynebacterium and provides epidemiological 
information on diseases caused by these microorganisms. The principal 
human pathogen of this genus, Corynebacterium diphtheriae, causes 
diphtheria. However, many other types of corynebacteria form part of the 
normal flora of the human respiratory tract, other mucus membranes, and 
skin, and are either nonpathogenic or have an uncertain role.

[[Page 269]]

    (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 Sec. 866.9.

[47 FR 50823, Nov. 9, 1982, as amended at 65 FR 2311, Jan. 14, 2000]