[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: 21CFR866.2410]

[Page 238]
 
                        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 C--Microbiology Devices
 
Sec. 866.2410  Culture medium for pathogenic Neisseria spp.

    (a) Identification. A culture medium for pathogenic Neisseria spp. 
is a device that consists primarily of liquid or solid biological 
materials used to cultivate and identify pathogenic Neisseria spp. The 
identification aids in the diagnosis of disease caused by bacteria 
belonging to the genus Neisseria, such as epidemic cerebrospinal 
meningitis, other meningococcal disease, and gonorrhea, and also 
provides epidemiological information on these microorganisms.
    (b) Classification. Class II (performance standards).