NOP · Elisa, Antibody, West Nile Virus
Microbiology · 21 CFR 866.3940 · Class 2
Overview
| Product Code | NOP |
|---|---|
| Device Name | Elisa, Antibody, West Nile Virus |
| Regulation | 21 CFR 866.3940 |
| Device Class | Class 2 |
| Review Panel | Microbiology |
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 Rationale
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.
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.
Recent Cleared Devices (10 of 10)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K153308 | EUROIMMUN Anti-West Nile Virus ELISA (IgM) | Euroimmun Us, Inc. | Aug 12, 2016 | SESE |
| K153303 | EUROIMMUN Anti-West Nile Virus ELISA (IgG) | Euroimmun Us, Inc. | Aug 10, 2016 | SESE |
| K052519 | SPECTRAL WEST NILE VIRUS IGM STATUS TEST | Spectral Diagnostics, Inc. | Nov 30, 2006 | SESE |
| K041817 | WEST NILE DETECT IGM ELISA | Inbios Intl., Inc. | Nov 19, 2004 | SESE |
| K041068 | WEST NILE VIRUS IGG INDIRECT ELISA | Panbio Limited | Oct 20, 2004 | SESE |
| K041231 | WEST NILE VIRUS IGM CAPTURE ELISA, MODEL E-WNV02M | Panbio Limited | Aug 10, 2004 | SESE |
| K040854 | WEST NILE VIRUS IGM CAPTURE ELISA | Focus Technologies, Inc. | Jun 30, 2004 | SESE |
| K031953 | WEST NILE VIRUS ELISA IGG, MODEL EL0300G | Focus Technologies, Inc. | Oct 22, 2003 | SESE |
| K031952 | WEST NILE VIRUS IGM CAPTURE ELISA, MODEL EL0300M | Focus Technologies, Inc. | Oct 22, 2003 | SESE |
| DEN030004 | WEST NILE VIRUS IGM CAPTURE ELISA | Panbio Limited | Jul 8, 2003 | DENG |
Top Applicants
- Panbio Limited — 3 clearances
- Focus Technologies, Inc. — 3 clearances
- Euroimmun Us, Inc. — 2 clearances
- Spectral Diagnostics, Inc. — 1 clearance
- Inbios Intl., Inc. — 1 clearance
