← Product Code [GMA](/submissions/MI/subpart-d%E2%80%94serological-reagents/GMA) · K802427

# LA-SPORO ANTIBODY SYSTEM (K802427)

_Immuno-Mycologics, Inc. · GMA · Oct 31, 1980 · Microbiology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/GMA/K802427

## Device Facts

- **Applicant:** Immuno-Mycologics, Inc.
- **Product Code:** [GMA](/submissions/MI/subpart-d%E2%80%94serological-reagents/GMA.md)
- **Decision Date:** Oct 31, 1980
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 866.3680
- **Device Class:** Class 1
- **Review Panel:** Microbiology

## Regulatory Identification

Sporothrix schenckii serological reagents are devices that consist of antigens and antisera used in serological tests to identify antibodies to Sporothrix schenckii in serum. The identification aids in the diagnosis of sporothrichosis caused by a fungus belonging to the genus Sporothrix and provides epidemiological information on this disease. Sporothrichosis is a chronic tumorlike infection primarily of the skin.

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**Source:** [https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/GMA/K802427](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/GMA/K802427)

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