← Product Code [KTN](/submissions/IM/subpart-f%E2%80%94immunological-test-systems/KTN) · K862008

# MONO-LATEX (TM) SLIDE TEST (K862008)

_Armkel, LLC · KTN · Jul 3, 1986 · Immunology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/KTN/K862008

## Device Facts

- **Applicant:** Armkel, LLC
- **Product Code:** [KTN](/submissions/IM/subpart-f%E2%80%94immunological-test-systems/KTN.md)
- **Decision Date:** Jul 3, 1986
- **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.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/KTN/K862008](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/KTN/K862008)

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