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866.3680—Sporothrix schenckii serological reagents.
(a)
Identification. Sporothrix schenckii serological reagents are devices that consist of antigens and antisera used in serological tests to identify antibodies to Sporothrix schenckii in serum. The identification aids in the diagnosis of sporothrichosis caused by a fungus belonging to the genus Sporothrix and provides epidemiological information on this disease. Sporothrichosis is a chronic tumorlike infection primarily of the skin.
(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 § 866.9.
Code of Federal Regulations
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