← Product Code [LLM](/submissions/MI/subpart-d%E2%80%94serological-reagents/LLM) · K946158

# INCSTAR EPSTEIN-BARR NUCLEAR ANTIGEN (EBNA_ IGG ELISA KIT (K946158)

_Incstar Corp. · LLM · Jun 9, 1995 · Microbiology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/LLM/K946158

## Device Facts

- **Applicant:** Incstar Corp.
- **Product Code:** [LLM](/submissions/MI/subpart-d%E2%80%94serological-reagents/LLM.md)
- **Decision Date:** Jun 9, 1995
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 866.3235
- **Device Class:** Class 1
- **Review Panel:** Microbiology

## Regulatory Identification

Epstein-Barr virus serological reagents are devices that consist of antigens and antisera used in serological tests to identify antibodies to Epstein-Barr virus in serum. The identification aids in the diagnosis of Epstein-Barr virus infections and provides epidemiological information on diseases caused by these viruses. Epstein-Barr viruses are thought to cause infectious mononucleosis and have been associated with Burkitt's lymphoma (a tumor of the jaw in African children and young adults) and postnasal carcinoma (cancer).

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**Source:** [https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/LLM/K946158](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/LLM/K946158)

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