(a)Identification. Blastomyces dermatitidis serological reagents are devices that consist of antigens and antisera used in serological tests to identify antibodies toBlastomyces determatitidis in serum. The identification aids in the diagnosis of blastomycosis caused by the fungusBlastomyces 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.
(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 866.9.
[47 FR 50823, Nov. 9, 1982, as amended at 63 FR 59226, Nov. 3, 1998]