IMMUNO-TEC II OT AGAROSE PLATE KIT
Device Facts
| Record ID | K761270 |
|---|---|
| Device Name | IMMUNO-TEC II OT AGAROSE PLATE KIT |
| Applicant | Behring Diagnostics, Inc. |
| Product Code | JZP · Immunology |
| Decision Date | Dec 30, 1976 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 866.4600 |
| Device Class | Class 1 |
Regulatory Classification
Identification
An ouchterlony agar plate for clinical use is a device containing an agar gel used to examine antigen-antibody reactions. In immunodiffusion, antibodies and antigens migrate toward each other through gel which originally contained neither of these reagents. As the reagents come in contact with each other, they combine to form a precipitate that is trapped in the gel matrix and is immobilized.
