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) → DGP — Ige, Fitc, Antigen, Antiserum, Control

# DGP · Ige, Fitc, 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/DGP

## Overview

- **Product Code:** DGP
- **Device Name:** Ige, Fitc, 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 (4 of 4)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K931224](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DGP/K931224.md) | VIDAS TOTAL IGE (IGE) ASSAY | Biomerieux Vitek, Inc. | May 20, 1993 | SESE |
| [K863327](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DGP/K863327.md) | IMMPULSE IGE ASSAY REAGENTS | Sclavo, Inc. | Dec 3, 1986 | SESE |
| [K842969](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DGP/K842969.md) | ALLERGENETICS ALLER-SPECIFIC IGE SERUM | Allergenetics | Aug 28, 1984 | SESE |
| [K842749](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DGP/K842749.md) | FIAX TOTAL IGE TEST KIT | Intl. Diagnostic Technology | Aug 28, 1984 | SESE |

## Top Applicants

- Allergenetics — 1 clearance
- Biomerieux Vitek, Inc. — 1 clearance
- Intl. Diagnostic Technology — 1 clearance
- Sclavo, Inc. — 1 clearance

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

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