Browse hierarchy: [Microbiology (MI)](/submissions/MI) → [Subpart D — Serological Reagents](/submissions/MI/subpart-d%E2%80%94serological-reagents) → [21 CFR 866.3085](/submissions/MI/subpart-d%E2%80%94serological-reagents/866.3085) → GSM — Antisera, Fluorescent, Brucella Spp.

# GSM · Antisera, Fluorescent, Brucella Spp.

_Microbiology · 21 CFR 866.3085 · Class 2_

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

## Overview

- **Product Code:** GSM
- **Device Name:** Antisera, Fluorescent, Brucella Spp.
- **Regulation:** [21 CFR 866.3085](/submissions/MI/subpart-d%E2%80%94serological-reagents/866.3085)
- **Device Class:** 2
- **Review Panel:** [Microbiology](/submissions/MI)

## Identification

Brucella spp. serological reagents are devices that consist of antigens and antisera used for serological identification of Brucella spp. from cultured isolates derived from clinical specimens or to identify antibodies to Brucella spp. in serum. Additionally, some of these reagents consist of antisera conjugated with a fluorescent dye (immunofluorescent reagents) used to identify Brucella spp. directly from clinical specimens or cultured isolates derived from clinical specimens. The identification aids in the diagnosis of brucellosis (e.g., undulant fever, Malta fever) caused by bacteria belonging to the genus Brucella and provides epidemiological information on diseases caused by these microorganisms.

## Classification Rationale

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

## Special Controls

*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 866.9.

## Recent Cleared Devices (4 of 4)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K952146](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/GSM/K952146.md) | SAS BRUCELLAS ABORTUS ANTISERUM | Sa Scientific, Inc. | Jul 21, 1995 | SESE |
| [K952144](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/GSM/K952144.md) | SAS BRUCELLA SUIS ANTISERUM | Sa Scientific, Inc. | Jul 21, 1995 | SESE |
| [K952143](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/GSM/K952143.md) | SAS BRUCELLA MELITENSIS ANTISERUM | Sa Scientific, Inc. | Jul 21, 1995 | SESE |
| [K952132](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/GSM/K952132.md) | SAS BRUCELLA AMS ANTISERUM | Sa Scientific, Inc. | Jul 21, 1995 | SESE |

## Top Applicants

- Sa Scientific, Inc. — 4 clearances

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

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