← Product Code [DGP](/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DGP) · K842749

# FIAX TOTAL IGE TEST KIT (K842749)

_Intl. Diagnostic Technology · DGP · Aug 28, 1984 · Immunology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DGP/K842749

## Device Facts

- **Applicant:** Intl. Diagnostic Technology
- **Product Code:** [DGP](/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DGP.md)
- **Decision Date:** Aug 28, 1984
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 866.5510
- **Device Class:** Class 2
- **Review Panel:** Immunology

## Regulatory 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.

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**Source:** [https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DGP/K842749](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DGP/K842749)

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