← Product Code [LHT](/submissions/MI/subpart-d%E2%80%94serological-reagents/LHT) · K820531

# ENDO-STAPH TEICHOIC ACID ANTIBODY KIT (K820531)

_Meridian Diagnostics, Inc. · LHT · Apr 14, 1982 · Microbiology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/LHT/K820531

## Device Facts

- **Applicant:** Meridian Diagnostics, Inc.
- **Product Code:** [LHT](/submissions/MI/subpart-d%E2%80%94serological-reagents/LHT.md)
- **Decision Date:** Apr 14, 1982
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 866.3700
- **Device Class:** Class 1
- **Review Panel:** Microbiology

## Regulatory Identification

Staphylococcus aureus serological reagents are devices that consist of antigens and antisera used in serological tests to identify enterotoxin (toxin affecting the intestine) producing staphylococci from cultured isolates. The identification aids in the diagnosis of disease caused by this bacterium belonging to the genus Staphylococcus and provides epidemiological information on these diseases. Certain strains of Staphylococcus aureus produce an enterotoxin while growing in meat, dairy, or bakery products. After ingestion, this enterotoxin is absorbed in the gut and causes destruction of the intestinal lining (gastroenteritis).

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**Source:** [https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/LHT/K820531](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/LHT/K820531)

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