← Product Code [KTN](/productcode/KTN) · K895765

# LEECO PREVIEW(R) EBV (EIA) (K895765)

_Leeco Diagnostics, Inc. · KTN · Oct 31, 1989 · Immunology · SESE_

**Canonical URL:** https://fda-staging.innolitics.com/device/K895765

## Device Facts

- **Applicant:** Leeco Diagnostics, Inc.
- **Product Code:** [KTN](/productcode/KTN.md)
- **Decision Date:** Oct 31, 1989
- **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/K895765](https://fda-staging.innolitics.com/device/K895765)

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