← Product Code [KTN](/productcode/KTN) · K844289

# SERIES I/S INFECTIONS (K844289)

_American Dade · KTN · Nov 19, 1984 · Immunology · SESE_

**Canonical URL:** https://fda-staging.innolitics.com/device/K844289

## Device Facts

- **Applicant:** American Dade
- **Product Code:** [KTN](/productcode/KTN.md)
- **Decision Date:** Nov 19, 1984
- **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/K844289](https://fda-staging.innolitics.com/device/K844289)

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