Browse hierarchy: [Microbiology (MI)](/submissions/MI) → [Subpart D — Serological Reagents](/submissions/MI/subpart-d%E2%80%94serological-reagents) → [21 CFR 866.3490](/submissions/MI/subpart-d%E2%80%94serological-reagents/866.3490) → GQE — Antisera, Neutralization, All Types, Rhinovirus

# GQE · Antisera, Neutralization, All Types, Rhinovirus

_Microbiology · 21 CFR 866.3490 · Class 1_

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

## Overview

- **Product Code:** GQE
- **Device Name:** Antisera, Neutralization, All Types, Rhinovirus
- **Regulation:** [21 CFR 866.3490](/submissions/MI/subpart-d%E2%80%94serological-reagents/866.3490)
- **Device Class:** 1
- **Review Panel:** [Microbiology](/submissions/MI)

## Identification

Rhinovirus serological reagents are devices that consist of antigens and antisera used in serological tests to identify antibodies to rhinovirus in serum. The identification aids in the diagnosis of rhinovirus infections and provides epidemiological information on diseases caused by these viruses. Rhinoviruses cause common colds.

## 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 (0 of 0)

_No cleared devices on record._

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

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