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Electronic Code of Federal Regulations

e-CFR data is current as of December 5, 2019

Title 21Chapter ISubchapter HPart 866Subpart D → §866.3940


Title 21: Food and Drugs
PART 866—IMMUNOLOGY AND MICROBIOLOGY DEVICES
Subpart D—Serological Reagents


§866.3940   West Nile virus serological reagents.

(a) Identification. West Nile virus serological reagents are devices that consist of antigens and antisera for the detection of anti-West Nile virus IgM antibodies, in human serum, from individuals who have signs and symptoms consistent with viral meningitis/encephalitis. The detection aids in the clinical laboratory diagnosis of viral meningitis/encephalitis caused by West Nile virus.

(b) Classification. Class II (special controls). The special control is FDA's guidance entitled “Class II Special Controls Guidance Document: Serological Reagents for the Laboratory Diagnosis of West Nile Virus.” See §866.1(e) for the availability of this guidance document.

[68 FR 61745, Oct. 30, 2003]

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