← Product Code [DGX](/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DGX) · K841114

# ALLO-TYPE HUMAN IMMUNOGLOBULIN- (K841114)

_Genetic Testing Institute · DGX · Jun 14, 1984 · Immunology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DGX/K841114

## Device Facts

- **Applicant:** Genetic Testing Institute
- **Product Code:** [DGX](/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DGX.md)
- **Decision Date:** Jun 14, 1984
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 866.5065
- **Device Class:** Class 1
- **Review Panel:** Immunology

## Regulatory Identification

A human allotypic marker immunological test system is a device that consists of the reagents used to identify by immunochemical techniques the inherited human protein allotypic markers (such as nGm, nA2 m, and Km allotypes) in serum and other body fluids. The identification may be used while studying population genetics.

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**Source:** [https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DGX/K841114](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DGX/K841114)

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