← Product Code [GOI](/submissions/MI/subpart-d%E2%80%94serological-reagents/GOI) · K820499

# FITC ANTI-RABIES MONOCLONAL GLOBULIN (K820499)

_Centocor, Inc. · GOI · Apr 16, 1982 · Microbiology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/GOI/K820499

## Device Facts

- **Applicant:** Centocor, Inc.
- **Product Code:** [GOI](/submissions/MI/subpart-d%E2%80%94serological-reagents/GOI.md)
- **Decision Date:** Apr 16, 1982
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 866.3460
- **Device Class:** Class 2
- **Review Panel:** Microbiology

## Regulatory Identification

Rabiesvirus immunofluorescent reagents are devices that consist of rabiesvirus antisera conjugated with a fluorescent dye used to identify rabiesvirus in specimens taken from suspected rabid animals. The identification aids in the diagnosis of rabies in patients exposed by animal bites and provides epidemiological information on rabies. Rabies is an acute infectious disease of the central nervous system which, if undiagnosed, may be fatal. The disease is commonly transmitted to humans by a bite from a rabid animal.

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**Source:** [https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/GOI/K820499](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/GOI/K820499)

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