← Product Code [JZQ](/submissions/IM/subpart-e%E2%80%94immunology-laboratory-equipment-and-reagents/JZQ) · K770548

# IMMUNOPLATE III RADIO IMMUNODIFFUSION (K770548)

_Hyland Therapeutic Div., Travenol Laboratories · JZQ · Apr 15, 1977 · Immunology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/IM/subpart-e%E2%80%94immunology-laboratory-equipment-and-reagents/JZQ/K770548

## Device Facts

- **Applicant:** Hyland Therapeutic Div., Travenol Laboratories
- **Product Code:** [JZQ](/submissions/IM/subpart-e%E2%80%94immunology-laboratory-equipment-and-reagents/JZQ.md)
- **Decision Date:** Apr 15, 1977
- **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.

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**Source:** [https://fda.innolitics.com/submissions/IM/subpart-e%E2%80%94immunology-laboratory-equipment-and-reagents/JZQ/K770548](https://fda.innolitics.com/submissions/IM/subpart-e%E2%80%94immunology-laboratory-equipment-and-reagents/JZQ/K770548)

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