Browse hierarchy: [Microbiology (MI)](/submissions/MI) → [Subpart D — Serological Reagents](/submissions/MI/subpart-d%E2%80%94serological-reagents) → [21 CFR 866.3940](/submissions/MI/subpart-d%E2%80%94serological-reagents/866.3940) → NOP — Elisa, Antibody, West Nile Virus

# NOP · Elisa, Antibody, West Nile Virus

_Microbiology · 21 CFR 866.3940 · Class 2_

**Canonical URL:** https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/NOP

## Overview

- **Product Code:** NOP
- **Device Name:** Elisa, Antibody, West Nile Virus
- **Regulation:** [21 CFR 866.3940](/submissions/MI/subpart-d%E2%80%94serological-reagents/866.3940)
- **Device Class:** 2
- **Review Panel:** [Microbiology](/submissions/MI)

## 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](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/NOP/K153308.md) | EUROIMMUN Anti-West Nile Virus ELISA (IgM) | Euroimmun Us, Inc. | Aug 12, 2016 | SESE |
| [K153303](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/NOP/K153303.md) | EUROIMMUN Anti-West Nile Virus ELISA (IgG) | Euroimmun Us, Inc. | Aug 10, 2016 | SESE |
| [K052519](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/NOP/K052519.md) | SPECTRAL WEST NILE VIRUS IGM STATUS TEST | Spectral Diagnostics, Inc. | Nov 30, 2006 | SESE |
| [K041817](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/NOP/K041817.md) | WEST NILE DETECT IGM ELISA | Inbios Intl., Inc. | Nov 19, 2004 | SESE |
| [K041068](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/NOP/K041068.md) | WEST NILE VIRUS IGG INDIRECT ELISA | Panbio Limited | Oct 20, 2004 | SESE |
| [K041231](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/NOP/K041231.md) | WEST NILE VIRUS IGM CAPTURE ELISA, MODEL E-WNV02M | Panbio Limited | Aug 10, 2004 | SESE |
| [K040854](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/NOP/K040854.md) | WEST NILE VIRUS IGM CAPTURE ELISA | Focus Technologies, Inc. | Jun 30, 2004 | SESE |
| [K031953](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/NOP/K031953.md) | WEST NILE VIRUS ELISA IGG, MODEL EL0300G | Focus Technologies, Inc. | Oct 22, 2003 | SESE |
| [K031952](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/NOP/K031952.md) | WEST NILE VIRUS IGM CAPTURE ELISA, MODEL EL0300M | Focus Technologies, Inc. | Oct 22, 2003 | SESE |
| [DEN030004](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/NOP/DEN030004.md) | WEST NILE VIRUS IGM CAPTURE ELISA | Panbio Limited | Jul 8, 2003 | DENG |

## Top Applicants

- Focus Technologies, Inc. — 3 clearances
- Panbio Limited — 3 clearances
- Euroimmun Us, Inc. — 2 clearances
- Inbios Intl., Inc. — 1 clearance
- Spectral Diagnostics, Inc. — 1 clearance

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**Source:** [https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/NOP](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/NOP)

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