← Product Code [KTN](/submissions/IM/subpart-f%E2%80%94immunological-test-systems/KTN) · K930778

# IMMUNOCARD MONO (K930778)

_Meridian Diagnostics, Inc. · KTN · Dec 27, 1993 · Immunology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/KTN/K930778

## Device Facts

- **Applicant:** Meridian Diagnostics, Inc.
- **Product Code:** [KTN](/submissions/IM/subpart-f%E2%80%94immunological-test-systems/KTN.md)
- **Decision Date:** Dec 27, 1993
- **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/K930778](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/KTN/K930778)

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