← Product Code [JZQ](/submissions/IM/subpart-e%E2%80%94immunology-laboratory-equipment-and-reagents/JZQ) · K881675

# IMMULON 4 FLAT BOTTOM PLATES & REMOVAWELL STRIPS (K881675)

_Dynatech Laboratories, Inc. · JZQ · Apr 21, 1988 · Immunology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/IM/subpart-e%E2%80%94immunology-laboratory-equipment-and-reagents/JZQ/K881675

## Device Facts

- **Applicant:** Dynatech Laboratories, Inc.
- **Product Code:** [JZQ](/submissions/IM/subpart-e%E2%80%94immunology-laboratory-equipment-and-reagents/JZQ.md)
- **Decision Date:** Apr 21, 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.

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**Source:** [https://fda.innolitics.com/submissions/IM/subpart-e%E2%80%94immunology-laboratory-equipment-and-reagents/JZQ/K881675](https://fda.innolitics.com/submissions/IM/subpart-e%E2%80%94immunology-laboratory-equipment-and-reagents/JZQ/K881675)

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