OUCHTERLONY AGAR PLATES
Device Facts
| Record ID | K792699 |
|---|---|
| Device Name | OUCHTERLONY AGAR PLATES |
| Applicant | Meridian Diagnostics, Inc. |
| Product Code | JZQ · Immunology |
| Decision Date | Jan 24, 1980 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 866.4800 |
| Device Class | Class 1 |
Regulatory Classification
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.
