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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: 21CFR866.2410]
See Related Information on Culture medium for pathogenicNeisseriaspp. 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 C--Microbiology Devices

Sec. 866.2410 Culture medium for pathogenicNeisseriaspp.

(a)Identification. A culture medium for pathogenicNeisseria spp. is a device that consists primarily of liquid or solid biological materials used to cultivate and identify pathogenicNeisseria spp. The identification aids in the diagnosis of disease caused by bacteria belonging to the genusNeisseria, such as epidemic cerebrospinal meningitis, other meningococcal disease, and gonorrhea, and also provides epidemiological information on these microorganisms.

(b)Classification. Class II (performance standards).

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