← Product Code [GPG](/submissions/MI/subpart-d%E2%80%94serological-reagents/GPG) · K904613

# TRICHINELLA SEROLOGY MICROTITER ELISA (K904613)

_Lmd Laboratories · GPG · Mar 21, 1991 · Microbiology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/GPG/K904613

## Device Facts

- **Applicant:** Lmd Laboratories
- **Product Code:** [GPG](/submissions/MI/subpart-d%E2%80%94serological-reagents/GPG.md)
- **Decision Date:** Mar 21, 1991
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 866.3850
- **Device Class:** Class 1
- **Review Panel:** Microbiology

## Regulatory Identification

Trichinella spiralis serological reagents are devices that consist of antigens and antisera used in serological tests to identify antibodies to Trichinella spiralis in serum. The identification aids in the diagnosis of trichinosis caused by parasitic roundworms belonging to the genus Trichinella and provides epidemiological information on trichinosis. Trichinosis is caused by ingestion of undercooked, infested meat, especially pork, and characterized by fever, muscle weakness, and diarrhea.

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**Source:** [https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/GPG/K904613](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/GPG/K904613)

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