[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: 21CFR866.3040]

[Page 251]
 
                        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. 866.3040  Aspergillus spp. serological reagents.

    (a) Identification. Aspergillus spp. serological reagents are 
devices that consist of antigens and antisera used in various 
serological tests to identify antibodies to Aspergillus spp. in serum. 
The identification aids in the diagnosis of aspergillosis caused by 
fungi belonging to the genus Aspergillus. Aspergillosis is a disease 
marked by inflammatory granulomatous (tumor-like) lessions in the skin, 
ear, eyeball cavity, nasal sinuses, lungs, and occasionally the bones.
    (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]