Browse hierarchy: [Immunology (IM)](/submissions/IM) → [Subpart F — Immunological Test Systems](/submissions/IM/subpart-f%E2%80%94immunological-test-systems) → [21 CFR 866.5510](/submissions/IM/subpart-f%E2%80%94immunological-test-systems/866.5510) → DGO — Ige, Peroxidase, Antigen, Antiserum, Control

# DGO · Ige, Peroxidase, Antigen, Antiserum, Control

_Immunology · 21 CFR 866.5510 · Class 2_

**Canonical URL:** https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DGO

## Overview

- **Product Code:** DGO
- **Device Name:** Ige, Peroxidase, Antigen, Antiserum, Control
- **Regulation:** [21 CFR 866.5510](/submissions/IM/subpart-f%E2%80%94immunological-test-systems/866.5510)
- **Device Class:** 2
- **Review Panel:** [Immunology](/submissions/IM)
- **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](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DGO/K943194.md) | IMMULITE(R) ALLERGY FOOD PANEL FP5E | Diagnostic Products Corp. | Feb 23, 1995 | SESE |
| [K920087](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DGO/K920087.md) | IGE EIA TEST KIT | The Binding Site, Ltd. | Sep 14, 1992 | SESE |
| [K911511](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DGO/K911511.md) | ALASTAT ALLERGEN SPECIFIED IGE SYSTEM, MODIFIED | Diagnostic Products Corp. | Apr 17, 1991 | SESE |
| [K894039](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DGO/K894039.md) | QUIDEL TOTAL IGE TEST QUANTITATIVE VERSION | Quidel Corp. | Jul 14, 1989 | SESE |
| [K893125](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DGO/K893125.md) | BECKMAN EPSILON(TM) IGE REAGENT KIT | Beckman Instruments, Inc. | Jun 16, 1989 | SESE |
| [K872801](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DGO/K872801.md) | ALLEIA TOTAL IGE EIA W/MONO ANTI. EKIE1, 2, 5 | Diagnostic Products Corp. | Sep 10, 1987 | SESE |
| [K860851](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DGO/K860851.md) | ALLEGRO IGE ENZYME IMMUNOASSAY SYSTEM | Nichols Institute Diagnostics | Mar 28, 1986 | SESE |
| [K853607](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DGO/K853607.md) | ALLERG-E IGE ENZYME IMMUNOASSAY KIT | Dexall Biomedical Labs, Inc. | Nov 7, 1985 | SESE |
| [K831984](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DGO/K831984.md) | POLYSTYRENE MICRO-LITER PLATE-BIRCHTREE | Diagnostic Reagent Tech. | Nov 21, 1983 | SESE |
| [K831987](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DGO/K831987.md) | EPSILON IGE TEST KIT | Beckman Instruments, Inc. | Oct 14, 1983 | SESE |
| [K831774](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DGO/K831774.md) | LOGIPE A DATA REDUCSYSTEM IP SPECIFIC- | Diagnostic Reagent Tech. | Jul 18, 1983 | SESE |
| [K830653](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DGO/K830653.md) | POLYSTYRENE MICROTITER PLATE IMMUNOSORB | Diagnostic Reagent Tech. | Apr 8, 1983 | SESE |
| [K830495](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DGO/K830495.md) | POLYSTYRENE MICROTITER PLATE IMMUNOSOR | Diagnostic Reagent Tech. | Apr 5, 1983 | SESE |
| [K821094](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DGO/K821094.md) | IP SPECIFIC E | Diagnostic Reagent Tech. | May 7, 1982 | SESE |
| [K800995](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DGO/K800995.md) | 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
- Calbiochem-Behring Corp. — 1 clearance
- Dexall Biomedical Labs, Inc. — 1 clearance

---

**Source:** [https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DGO](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DGO)

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