[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: 21CFR866.3125]

[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. 866.3125  Citrobacter spp. serological reagents.

    (a) Identification. Citrobacter spp. serological reagents are 
devices that consist of antigens and antisera used in serological tests 
to identify Citrobacter spp. from cultured isolates derived from 
clinical specimens. The identification aids in the diagnosis of disease 
caused by bacteria belonging to the genus Citrobacter and provides 
epidemiological information on diseases caused by these microorganisms. 
Citrobacter spp. have occasionally been associated with urinary tract 
infections.
    (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]