← Product Code [GNW](/submissions/MI/subpart-d%E2%80%94serological-reagents/GNW) · K913214

# INFLUENZA MAB TEST/INFLUENZA B TEST (K913214)

_Gull Laboratories, Inc. · GNW · Dec 13, 1991 · Microbiology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/GNW/K913214

## Device Facts

- **Applicant:** Gull Laboratories, Inc.
- **Product Code:** [GNW](/submissions/MI/subpart-d%E2%80%94serological-reagents/GNW.md)
- **Decision Date:** Dec 13, 1991
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 866.3330
- **Device Class:** Class 1
- **Review Panel:** Microbiology

## Regulatory Identification

Influenza virus serological reagents are devices that consist of antigens and antisera used in serological tests to identify antibodies to influenza in serum. The identification aids in the diagnosis of influenza (flu) and provides epidemiological information on influenza. Influenza is an acute respiratory tract disease, which is often epidemic.

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**Source:** [https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/GNW/K913214](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/GNW/K913214)

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