← Product Code [JZQ](/submissions/IM/subpart-e%E2%80%94immunology-laboratory-equipment-and-reagents/JZQ) · K790646

# HELENA QUIPLATE SYSTEM (K790646)

_Helena Laboratories · JZQ · May 23, 1979 · Immunology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/IM/subpart-e%E2%80%94immunology-laboratory-equipment-and-reagents/JZQ/K790646

## Device Facts

- **Applicant:** Helena Laboratories
- **Product Code:** [JZQ](/submissions/IM/subpart-e%E2%80%94immunology-laboratory-equipment-and-reagents/JZQ.md)
- **Decision Date:** May 23, 1979
- **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/K790646](https://fda.innolitics.com/submissions/IM/subpart-e%E2%80%94immunology-laboratory-equipment-and-reagents/JZQ/K790646)

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