← Product Code [GNX](/submissions/MI/subpart-d%E2%80%94serological-reagents/GNX) · K884191

# INFLUENZA A IFA TEST FOR DIRECT ANTIGEN DETECTION (K884191)

_Baxter Diagnostics, Inc. · GNX · Nov 22, 1988 · Microbiology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/GNX/K884191

## Device Facts

- **Applicant:** Baxter Diagnostics, Inc.
- **Product Code:** [GNX](/submissions/MI/subpart-d%E2%80%94serological-reagents/GNX.md)
- **Decision Date:** Nov 22, 1988
- **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/GNX/K884191](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/GNX/K884191)

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