← Product Code [NOP](/submissions/MI/subpart-d%E2%80%94serological-reagents/NOP) · DEN030004

# WEST NILE VIRUS IGM CAPTURE ELISA (DEN030004)

_Panbio Limited · NOP · Jul 8, 2003 · Microbiology · DENG_

**Canonical URL:** https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/NOP/DEN030004

## Device Facts

- **Applicant:** Panbio Limited
- **Product Code:** [NOP](/submissions/MI/subpart-d%E2%80%94serological-reagents/NOP.md)
- **Decision Date:** Jul 8, 2003
- **Decision:** DENG
- **Submission Type:** Post-NSE
- **Regulation:** 21 CFR 866.3940
- **Device Class:** Class 2
- **Review Panel:** Microbiology

## Regulatory 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.

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**Source:** [https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/NOP/DEN030004](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/NOP/DEN030004)

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