IMMULON 4 FLAT BOTTOM PLATES & REMOVAWELL STRIPS
Device Facts
| Record ID | K881675 |
|---|---|
| Device Name | IMMULON 4 FLAT BOTTOM PLATES & REMOVAWELL STRIPS |
| Applicant | Dynatech Laboratories, Inc. |
| Product Code | JZQ · Immunology |
| Decision Date | Apr 21, 1988 |
| 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.
