← Product Code [GOD](/submissions/MI/subpart-d%E2%80%94serological-reagents/GOD) · K864645

# ADENOLEX (R) LATEX AGGLUTINATION TEST (K864645)

_Orion Diagnostica, Inc. · GOD · Jun 4, 1987 · Microbiology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/GOD/K864645

## Device Facts

- **Applicant:** Orion Diagnostica, Inc.
- **Product Code:** [GOD](/submissions/MI/subpart-d%E2%80%94serological-reagents/GOD.md)
- **Decision Date:** Jun 4, 1987
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 866.3020
- **Device Class:** Class 1
- **Review Panel:** Microbiology

## Regulatory Identification

Adenovirus serological reagents are devices that consist of antigens and antisera used in serological tests to identify antibodies to adenovirus in serum. Additionally, some of these reagents consist of adenovirus antisera conjugated with a fluorescent dye and are used to identify adenoviruses directly from clinical specimens. The identification aids in the diagnosis of disease caused by adenoviruses and provides epidemiological information on these diseases. Adenovirus infections may cause pharyngitis (inflammation of the throat), acute respiratory diseases, and certain external diseases of the eye (e.g., conjunctivitis).

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**Source:** [https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/GOD/K864645](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/GOD/K864645)

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