(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]