← Product Code [JZQ](/submissions/IM/subpart-e%E2%80%94immunology-laboratory-equipment-and-reagents/JZQ) · K761311

# ACCRAASSAY RID KITS (K761311)

_Miles Laboratories, Inc. · JZQ · Dec 30, 1976 · Immunology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/IM/subpart-e%E2%80%94immunology-laboratory-equipment-and-reagents/JZQ/K761311

## Device Facts

- **Applicant:** Miles Laboratories, Inc.
- **Product Code:** [JZQ](/submissions/IM/subpart-e%E2%80%94immunology-laboratory-equipment-and-reagents/JZQ.md)
- **Decision Date:** Dec 30, 1976
- **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/K761311](https://fda.innolitics.com/submissions/IM/subpart-e%E2%80%94immunology-laboratory-equipment-and-reagents/JZQ/K761311)

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