Browse hierarchy: [Microbiology (MI)](/submissions/MI) → [Subpart D — Serological Reagents](/submissions/MI/subpart-d%E2%80%94serological-reagents) → [21 CFR 866.3250](/submissions/MI/subpart-d%E2%80%94serological-reagents/866.3250) → GSF — Antigen, Erysipelothrix Rhusiopathiae

# GSF · Antigen, Erysipelothrix Rhusiopathiae

_Microbiology · 21 CFR 866.3250 · Class 1_

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

## Overview

- **Product Code:** GSF
- **Device Name:** Antigen, Erysipelothrix Rhusiopathiae
- **Regulation:** [21 CFR 866.3250](/submissions/MI/subpart-d%E2%80%94serological-reagents/866.3250)
- **Device Class:** 1
- **Review Panel:** [Microbiology](/submissions/MI)

## Identification

Erysipelothrix rhusiopathiae serological reagents are devices that consist of antigens and antisera used in serological tests to identify Erysipelothrix rhusiopathiae from cultured isolates derived from clinical specimens. The identification aids in the diagnosis of disease caused by this bacterium belonging to the genus Erysipelothrix. This organism is responsible for a variety of inflammations of the skin following skin abrasions from contact with fish, shellfish, or poultry.

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

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