← Product Code [GMP](/submissions/MI/subpart-d%E2%80%94serological-reagents/GMP) · K885298

# VISUWELL REAGIN TEST 960 TEST KIT (K885298)

_Allelix Diagnostics, Inc. · GMP · Mar 15, 1989 · Microbiology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/GMP/K885298

## Device Facts

- **Applicant:** Allelix Diagnostics, Inc.
- **Product Code:** [GMP](/submissions/MI/subpart-d%E2%80%94serological-reagents/GMP.md)
- **Decision Date:** Mar 15, 1989
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 866.3820
- **Device Class:** Class 2
- **Review Panel:** Microbiology

## Regulatory Identification

Treponema pallidum nontreponemal test reagents are devices that consist of antigens derived from nontreponemal sources (sources not directly associated with treponemal organisms) and control sera (standardized sera with which test results are compared) used in serological tests to identify reagin, an antibody-like agent, which is produced from the reaction of treponema microorganisms with body tissues. The identification aids in the diagnosis of syphilis caused by microorganisms belonging to the genus Treponema and provides epidemiological information on syphilis.

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**Source:** [https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/GMP/K885298](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/GMP/K885298)

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