← Product Code [JZQ](/submissions/IM/subpart-e%E2%80%94immunology-laboratory-equipment-and-reagents/JZQ) · K881174

# RID PLATE READER (K881174)

_The Binding Site, Ltd. · JZQ · Jun 8, 1988 · Immunology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/IM/subpart-e%E2%80%94immunology-laboratory-equipment-and-reagents/JZQ/K881174

## Device Facts

- **Applicant:** The Binding Site, Ltd.
- **Product Code:** [JZQ](/submissions/IM/subpart-e%E2%80%94immunology-laboratory-equipment-and-reagents/JZQ.md)
- **Decision Date:** Jun 8, 1988
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 866.4800
- **Device Class:** Class 1
- **Review Panel:** Immunology

## Regulatory Identification

A radial immunodiffusion plate for clinical use is a device that consists of a plastic plate to which agar gel containing antiserum is added. In radial immunodiffusion, antigens migrate through gel which originally contains specific antibodies. As the reagents come in contact with each other, they combine to form a precipitate that is trapped in the gel matrix and immobilized.

---

**Source:** [https://fda.innolitics.com/submissions/IM/subpart-e%E2%80%94immunology-laboratory-equipment-and-reagents/JZQ/K881174](https://fda.innolitics.com/submissions/IM/subpart-e%E2%80%94immunology-laboratory-equipment-and-reagents/JZQ/K881174)

**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