[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: 21CFR866.3135]

[Page 268]
 
                        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. 866.3135  Coccidioides immitis serological reagents.

    (a) Identification. Coccidioides immitis serological reagents are 
devices that consist of antigens and antisera used in serological tests 
to identify antibodies to Coccidioides immitis in serum. The 
identification aids in the diagnosis of coccidioidomycosis caused by a 
fungus belonging to the genus Coccidioides and provides epidemiological 
information on diseases caused by this microorganism. An infection with 
Coccidioides immitis produces symptoms varying in severity from those 
accompanying the common cold to those of influenza.
    (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]