[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: 21CFR866.3165]

[Page 253]
 
                        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. 866.3165  Cryptococcus neoformans serological reagents.

    (a) Identification. Cryptococcus neoformans serological reagents are 
devices that consist of antigens used in serological tests to identify 
antibodies to Cryptococcus neoformans in serum. Additionally, some of 
these reagents consist of antisera conjugated with a fluorescent dye 
(immunofluorescent reagents) and are used to identify Cryptococcus 
neoformans directly from clinical specimens or from cultured isolates 
derived from clinical specimens. The identification aids in the 
diagnosis of cryptococcosis and provides epidemiological information on 
this type of disease. Cryptococcosis infections are found most often as 
chronic meningitis (inflammation of brain membranes) and, if not 
treated, are usually fatal.
    (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]