[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2008]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR866.3060]

[Page 261-262]
 
                        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. 866.3060  Blastomyces dermatitidis serological reagents.

    (a) Identification. Blastomyces dermatitidis serological reagents 
are devices that consist of antigens and antisera used in serological 
tests to identify antibodies to Blastomyces determatitidis in serum. The 
identification aids in the diagnosis of blastomycosis caused by the 
fungus Blastomyces dermatitidis. Blastomycosis is a chronic 
granulomatous (tumor-like) disease, which may be limited to the skin or 
lung or may be widely disseminated in the body resulting in lesions of 
the bones, liver, spleen, and kidneys.

[[Page 262]]

    (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]