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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: 21CFR866.3085]
See Related Information on Brucellaspp. serological 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. 866.3085 Brucellaspp. serological reagents.

(a)Identification. Brucella spp. serological reagents are devices that consist of antigens and antisera used for serological identification ofBrucella spp. from cultured isolates derived from clinical specimens or to identify antibodies toBrucella spp. in serum. Additionally, some of these reagents consist of antisera conjugated with a fluorescent dye (immunofluorescent reagents) used to identifyBrucella spp. directly from clinical specimens or cultured isolates derived from clinical specimens. The identification aids in the diagnosis of brucellosis (e.g., undulant fever, Malta fever) caused by bacteria belonging to the genusBrucella and provides epidemiological information on diseases caused by these microorganisms.

(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]

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