Browse hierarchy: [Microbiology (MI)](/submissions/MI) → [Subpart D — Serological Reagents](/submissions/MI/subpart-d%E2%80%94serological-reagents) → [21 CFR 866.3330](/submissions/MI/subpart-d%E2%80%94serological-reagents/866.3330) → GNS — Antisera, Hai, Influenza Virus A, B, C

# GNS · Antisera, Hai, Influenza Virus A, B, C

_Microbiology · 21 CFR 866.3330 · Class 1_

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

## Overview

- **Product Code:** GNS
- **Device Name:** Antisera, Hai, Influenza Virus A, B, C
- **Regulation:** [21 CFR 866.3330](/submissions/MI/subpart-d%E2%80%94serological-reagents/866.3330)
- **Device Class:** 1
- **Review Panel:** [Microbiology](/submissions/MI)

## 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.

## Classification Rationale

Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 866.9.

## Recent Cleared Devices (9 of 9)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K780697](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/GNS/K780697.md) | GOAT ANTI-INFLUENZA ANTISERA ATEXAS | Northeast Biomedical Labs., Inc. | May 3, 1978 | SESE |
| [K780696](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/GNS/K780696.md) | GOAT ANTIINFLUENZA ANTISERA AUSSR | Northeast Biomedical Labs., Inc. | May 3, 1978 | SESE |
| [K780277](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/GNS/K780277.md) | INFLUENZA HI PRESERUM A/TEXAS | Flow Laboratories, Inc. | Feb 28, 1978 | SESE |
| [K780276](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/GNS/K780276.md) | INFLUENZA HI ANTISERUM A/TEXAS | Flow Laboratories, Inc. | Feb 28, 1978 | SESE |
| [K780274](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/GNS/K780274.md) | INFLUENZA HI ANTISERUM | Flow Laboratories, Inc. | Feb 28, 1978 | SESE |
| [K780273](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/GNS/K780273.md) | INFLUENZA HI PRESERUM | Flow Laboratories, Inc. | Feb 28, 1978 | SESE |
| [K780006](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/GNS/K780006.md) | GOAT ANTI-INFLUENZA ANTISERA | Northeast Biomedical Labs., Inc. | Jan 20, 1978 | SESE |
| [K780005](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/GNS/K780005.md) | GOAT ANTI-INFLUENZA ANTISERA | Northeast Biomedical Labs., Inc. | Jan 20, 1978 | SESE |
| [K780004](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/GNS/K780004.md) | GOAT ANTI-INFLUENZA ANTISERA | Northeast Biomedical Labs., Inc. | Jan 20, 1978 | SESE |

## Top Applicants

- Northeast Biomedical Labs., Inc. — 5 clearances
- Flow Laboratories, Inc. — 4 clearances

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

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