← Product Code [GRE](/submissions/MI/subpart-d%E2%80%94serological-reagents/GRE) · K853067

# FIAX TEST KIT FOR MEASLES-G ANTIBODIES FLYORESCENT (K853067)

_Idt, A Division of Whittaker M.A. Bioproducts · GRE · Oct 22, 1985 · Microbiology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/GRE/K853067

## Device Facts

- **Applicant:** Idt, A Division of Whittaker M.A. Bioproducts
- **Product Code:** [GRE](/submissions/MI/subpart-d%E2%80%94serological-reagents/GRE.md)
- **Decision Date:** Oct 22, 1985
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 866.3520
- **Device Class:** Class 1
- **Review Panel:** Microbiology

## Regulatory Identification

Rubeola (measles) virus serological reagents are devices that consist of antigens and antisera used in serological tests to identify antibodies to rubeola virus in serum. The identification aids in the diagnosis of measles and provides epidemiological information on the disease. Measles is an acute, highly infectious disease of the respiratory and reticuloendothelial tissues, particularly in children, characterized by a confluent and blotchy rash.

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**Source:** [https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/GRE/K853067](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/GRE/K853067)

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