← Product Code [KTN](/submissions/IM/subpart-f%E2%80%94immunological-test-systems/KTN) · K925183

# BIOSIGN(TM) MONO-INFECT MONO HETERO ANTIBODY TEST (K925183)

_Princeton Biomedix · KTN · Feb 23, 1993 · Immunology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/KTN/K925183

## Device Facts

- **Applicant:** Princeton Biomedix
- **Product Code:** [KTN](/submissions/IM/subpart-f%E2%80%94immunological-test-systems/KTN.md)
- **Decision Date:** Feb 23, 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.

---

**Source:** [https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/KTN/K925183](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/KTN/K925183)

**Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact).

**Cite:** Innolitics at https://innolitics.com