# Elisa, Antibody, West Nile Virus
> **Product code: NOP** · Class II — Moderate Risk (510(k) clearance required) · Microbiology · 21 CFR 866.3940
## Classification
- **FDA Product Code:** NOP
- **Device class:** Class II — Moderate Risk (510(k) clearance required)
- **Regulation:** 21 CFR 866.3940
- **Review panel:** MI
- **Medical specialty:** Microbiology
- **Submission type:** 1
- **GMP exempt:** N
- **Life sustaining:** N
- **Implant:** N
- **Third-party review:** N
## Definition

The West Nile Virus ELISA is intended for the detection of IgG and IgM antibodies to West Nile Virus. Specimens may be serum or cerebral spinal fluid from symptomatic patients.

## Market data
- **Cleared 510(k) submissions:** 10
- **Registered establishments:** 9
## Source
- [FDA Device Classification](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/classification.cfm?ID=NOP)
---
*AI Analytics · CC0 1.0*