Browse hierarchy: [Microbiology (MI)](/submissions/MI) → [Subpart D — Serological Reagents](/submissions/MI/subpart-d%E2%80%94serological-reagents) → [21 CFR 866.3255](/submissions/MI/subpart-d%E2%80%94serological-reagents/866.3255) → GMY — Antisera, Fluorescent, All Types, Escherichia Coli

# GMY · Antisera, Fluorescent, All Types, Escherichia Coli

_Microbiology · 21 CFR 866.3255 · Class 1_

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

## Overview

- **Product Code:** GMY
- **Device Name:** Antisera, Fluorescent, All Types, Escherichia Coli
- **Regulation:** [21 CFR 866.3255](/submissions/MI/subpart-d%E2%80%94serological-reagents/866.3255)
- **Device Class:** 1
- **Review Panel:** [Microbiology](/submissions/MI)

## Identification

Escherichia coli serological reagents are devices that consist of antigens and antisera used in serological tests to identify Escherichia coli from cultured isolates derived from clinical specimens. Additionally, some of these reagents consist of Escherichia coli antisera conjugated with a fluorescent dye used to identify Escherichia coli directly from clinical specimens or cultured isolates derived from clinical specimens. The identification aids in the diagnosis of diseases caused by this bacterium belonging to the genus Escherichia, and provides epidemiological information on diseases caused by this microorganism. Although Escherichia coli constitutes the greater part of the microorganisms found in the intestinal tract in humans and is usually nonpathogenic, those strains which are pathogenic may cause urinary tract infections or epidemic diarrheal disease, especially in children.

## 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 (2 of 2)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K770833](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/GMY/K770833.md) | FLUORETEC-M | Pfizer, Inc. | Jun 8, 1977 | SESE |
| [K770801](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/GMY/K770801.md) | MICROBIO. PROD. FLUORESCENT ANTIBODY | Pfizer Pharmaceuticals | May 25, 1977 | SESE |

## Top Applicants

- Pfizer Pharmaceuticals — 1 clearance
- Pfizer, Inc. — 1 clearance

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

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