West Nile virus serological reagents.
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.
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.