DGO · Ige, Peroxidase, Antigen, Antiserum, Control
Immunology · 21 CFR 866.5510 · Class 2
Overview
| Product Code | DGO |
|---|---|
| Device Name | Ige, Peroxidase, Antigen, Antiserum, Control |
| Regulation | 21 CFR 866.5510 |
| Device Class | Class 2 |
| Review Panel | Immunology |
| 3rd-Party Reviewable | Yes |
Identification
An immunoglobulins A, G, M, D, and E immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the immunoglobulins A, G, M, D, an E (serum antibodies) in serum. Measurement of these immunoglobulins aids in the diagnosis of abnormal protein metabolism and the body's lack of ability to resist infectious agents.
Classification Rationale
Class II (performance standards).
Recent Cleared Devices (15 of 15)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K943194 | IMMULITE(R) ALLERGY FOOD PANEL FP5E | Diagnostic Products Corp. | Feb 23, 1995 | SESE |
| K920087 | IGE EIA TEST KIT | The Binding Site, Ltd. | Sep 14, 1992 | SESE |
| K911511 | ALASTAT ALLERGEN SPECIFIED IGE SYSTEM, MODIFIED | Diagnostic Products Corp. | Apr 17, 1991 | SESE |
| K894039 | QUIDEL TOTAL IGE TEST QUANTITATIVE VERSION | Quidel Corp. | Jul 14, 1989 | SESE |
| K893125 | BECKMAN EPSILON(TM) IGE REAGENT KIT | Beckman Instruments, Inc. | Jun 16, 1989 | SESE |
| K872801 | ALLEIA TOTAL IGE EIA W/MONO ANTI. EKIE1, 2, 5 | Diagnostic Products Corp. | Sep 10, 1987 | SESE |
| K860851 | ALLEGRO IGE ENZYME IMMUNOASSAY SYSTEM | Nichols Institute Diagnostics | Mar 28, 1986 | SESE |
| K853607 | ALLERG-E IGE ENZYME IMMUNOASSAY KIT | Dexall Biomedical Labs, Inc. | Nov 7, 1985 | SESE |
| K831984 | POLYSTYRENE MICRO-LITER PLATE-BIRCHTREE | Diagnostic Reagent Tech. | Nov 21, 1983 | SESE |
| K831987 | EPSILON IGE TEST KIT | Beckman Instruments, Inc. | Oct 14, 1983 | SESE |
| K831774 | LOGIPE A DATA REDUCSYSTEM IP SPECIFIC- | Diagnostic Reagent Tech. | Jul 18, 1983 | SESE |
| K830653 | POLYSTYRENE MICROTITER PLATE IMMUNOSORB | Diagnostic Reagent Tech. | Apr 8, 1983 | SESE |
| K830495 | POLYSTYRENE MICROTITER PLATE IMMUNOSOR | Diagnostic Reagent Tech. | Apr 5, 1983 | SESE |
| K821094 | IP SPECIFIC E | Diagnostic Reagent Tech. | May 7, 1982 | SESE |
| K800995 | IMMUNOGLOBULIN E TEST KIT | Calbiochem-Behring Corp. | May 14, 1980 | SESE |
Top Applicants
- Diagnostic Reagent Tech. — 5 clearances
- Diagnostic Products Corp. — 3 clearances
- Beckman Instruments, Inc. — 2 clearances
- The Binding Site, Ltd. — 1 clearance
- Quidel Corp. — 1 clearance
