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U.S. Department of Health and Human Services

CFR - Code of Federal Regulations Title 21

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Help | More About 21CFR
[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2013]
[CITE: 21CFR866.3680]
See Related Information on Sporothrix schenckiiserological reagents. in CDRH databases



TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER H--MEDICAL DEVICES

PART 866 -- IMMUNOLOGY AND MICROBIOLOGY DEVICES

Subpart D--Serological Reagents

Sec. 866.3680 Sporothrix schenckiiserological reagents.

(a)Identification. Sporothrix schenckii serological reagents are devices that consist of antigens and antisera used in serological tests to identify antibodies toSporothrix schenckii in serum. The identification aids in the diagnosis of sporothrichosis caused by a fungus belonging to the genusSporothrix 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.

[47 FR 50823, Nov. 9, 1982, as amended at 65 FR 2312, Jan. 14, 2000]

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