← Product Code [KTN](/productcode/KTN) · K902541

# MONO-LEX SYSTEM: INFECTIOUS MONONUCLEOSIS LATEX (K902541)

_Trinity Laboratories, Inc. · KTN · Jun 28, 1990 · Immunology · SESE_

**Canonical URL:** https://fda-staging.innolitics.com/device/K902541

## Device Facts

- **Applicant:** Trinity Laboratories, Inc.
- **Product Code:** [KTN](/productcode/KTN.md)
- **Decision Date:** Jun 28, 1990
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 866.5640
- **Device Class:** Class 2
- **Review Panel:** Immunology

## Regulatory Identification

An infectious mononucleosis immunological test system is a device that consists of the reagents used to measure by immunochemical techniques heterophile antibodies frequently associated with infectious mononucleosis in serum, plasma, and other body fluids. Measurements of these antibodies aid in the diagnosis of infectious mononucleosis.

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**Source:** [https://fda-staging.innolitics.com/device/K902541](https://fda-staging.innolitics.com/device/K902541)

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