JZQ · Plates And Equipment, Radial Immunodiffusion
Immunology · 21 CFR 866.4800 · Class 1
Overview
| Product Code | JZQ |
|---|---|
| Device Name | Plates And Equipment, Radial Immunodiffusion |
| Regulation | 21 CFR 866.4800 |
| Device Class | Class 1 |
| Review Panel | Immunology |
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.
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 (7 of 7)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K881174 | RID PLATE READER | The Binding Site, Ltd. | Jun 8, 1988 | SESE |
| K881675 | IMMULON 4 FLAT BOTTOM PLATES & REMOVAWELL STRIPS | Dynatech Laboratories, Inc. | Apr 21, 1988 | SESE |
| K831811 | REVOLUTION RADIAL IMMUNODIFFUSION PLATE | Calbiochem-Behring Corp. | Jul 28, 1983 | SESE |
| K792699 | OUCHTERLONY AGAR PLATES | Meridian Diagnostics, Inc. | Jan 24, 1980 | SESE |
| K790646 | HELENA QUIPLATE SYSTEM | Helena Laboratories | May 23, 1979 | SESE |
| K770548 | IMMUNOPLATE III RADIO IMMUNODIFFUSION | Hyland Therapeutic Div., Travenol Laboratories | Apr 15, 1977 | SESE |
| K761311 | ACCRAASSAY RID KITS | Miles Laboratories, Inc. | Dec 30, 1976 | SESE |
Top Applicants
- Calbiochem-Behring Corp. — 1 clearance
- Dynatech Laboratories, Inc. — 1 clearance
- Helena Laboratories — 1 clearance
- Hyland Therapeutic Div., Travenol Laboratories — 1 clearance
- Meridian Diagnostics, Inc. — 1 clearance
