JZP · Plates, Ouchterlony Agar
Immunology · 21 CFR 866.4600 · Class 1
Overview
| Product Code | JZP |
|---|---|
| Device Name | Plates, Ouchterlony Agar |
| Regulation | 21 CFR 866.4600 |
| Device Class | Class 1 |
| Review Panel | Immunology |
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.
Classification Rationale
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 866.9.
Recent Cleared Devices (1 of 1)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K761270 | IMMUNO-TEC II OT AGAROSE PLATE KIT | Behring Diagnostics, Inc. | Dec 30, 1976 | SESE |
Top Applicants
- Behring Diagnostics, Inc. — 1 clearance
