Browse hierarchy: [Microbiology (MI)](/submissions/MI) → [Subpart D — Serological Reagents](/submissions/MI/subpart-d%E2%80%94serological-reagents) → [21 CFR 866.3240](/submissions/MI/subpart-d%E2%80%94serological-reagents/866.3240) → GQC — Antisera, Cf, Equine Encephalitis Virus, Eee, Wee

# GQC · Antisera, Cf, Equine Encephalitis Virus, Eee, Wee

_Microbiology · 21 CFR 866.3240 · Class 1_

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

## Overview

- **Product Code:** GQC
- **Device Name:** Antisera, Cf, Equine Encephalitis Virus, Eee, Wee
- **Regulation:** [21 CFR 866.3240](/submissions/MI/subpart-d%E2%80%94serological-reagents/866.3240)
- **Device Class:** 1
- **Review Panel:** [Microbiology](/submissions/MI)

## Identification

Equine encephalomyelitis virus serological reagents are devices that consist of antigens and antisera used in serological tests to identify antobodies to equine encephalomyelitis virus in serum. The identification aids in the diagnosis of diseases caused by equine encephalomyelitis viruses and provides epidemiological information on these viruses. Equine encephalomyelitis viruses are transmitted to humans by the bite of insects, such as mosquitos and ticks, and may cause encephalitis (inflammation of the brain), rash, acute arthritis, or hepatitis.

## 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 § 866.9.

## Recent Cleared Devices (2 of 2)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K913618](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/GQC/K913618.md) | ARBOVIRUS IGM IFA TEST | Hillcrest Biologicals | Dec 3, 1992 | SESE |
| [K913617](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/GQC/K913617.md) | ARBOVIRUS IGG IFA TEST | Hillcrest Biologicals | Dec 3, 1992 | SESE |

## Top Applicants

- Hillcrest Biologicals — 2 clearances

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

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