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) → DGE — Igd, Rhodamine, Antigen, Antiserum, Control

# DGE · Igd, Rhodamine, 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/DGE

## Overview

- **Product Code:** DGE
- **Device Name:** Igd, Rhodamine, 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 (2 of 2)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K915838](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DGE/K915838.md) | OPUS FERRITIN TEST SYSTEM | Pb Diagnostic Systems, Inc. | Mar 18, 1992 | SESE |
| [K871972](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DGE/K871972.md) | STRATUS IGE FLUOROMETRIC ENZYME IMMUNOASSAY | American Dade | Jul 21, 1987 | SESE |

## Top Applicants

- Pb Diagnostic Systems, Inc. — 1 clearance
- American Dade — 1 clearance

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

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