WEST NILE VIRUS IGM CAPTURE ELISA
Device Facts
| Record ID | DEN030004 |
|---|---|
| Device Name | WEST NILE VIRUS IGM CAPTURE ELISA |
| Applicant | Panbio Limited |
| Product Code | NOP · Microbiology |
| Decision Date | Jul 8, 2003 |
| Decision | DENG |
| Submission Type | Post-NSE |
| Regulation | 21 CFR 866.3940 |
| Device Class | Class 2 |
Regulatory Classification
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.
Special Controls
*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.
