Browse hierarchy: [Microbiology (MI)](/submissions/MI) → [Subpart D — Serological Reagents](/submissions/MI/subpart-d%E2%80%94serological-reagents) → [21 CFR 866.3470](/submissions/MI/subpart-d%E2%80%94serological-reagents/866.3470) → GQB — Antigens, Cf (Including Cf Control), Reovirus 1-3

# GQB · Antigens, Cf (Including Cf Control), Reovirus 1-3

_Microbiology · 21 CFR 866.3470 · Class 1_

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

## Overview

- **Product Code:** GQB
- **Device Name:** Antigens, Cf (Including Cf Control), Reovirus 1-3
- **Regulation:** [21 CFR 866.3470](/submissions/MI/subpart-d%E2%80%94serological-reagents/866.3470)
- **Device Class:** 1
- **Review Panel:** [Microbiology](/submissions/MI)

## Identification

Reovirus serological reagents are devices that consist of antigens and antisera used in serological tests to identify antibodies to reovirus in serum. The identification aids in the diagnosis of reovirus infections and provides epidemiological information on diseases caused by these viruses. Reoviruses are thought to cause only mild respiratory and gastrointestinal illnesses.

## 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/GQB](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/GQB)

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