HELENA QUIPLATE SYSTEM
Device Facts
| Record ID | K790646 |
|---|---|
| Device Name | HELENA QUIPLATE SYSTEM |
| Applicant | Helena Laboratories |
| Product Code | JZQ · Immunology |
| Decision Date | May 23, 1979 |
| 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.
