§ 866.3940. West Nile virus serological reagents.
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/us/cfr/t21/s§ 866.3940·A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
(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]