← Product Code [DAS](/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DAS) · K943205

# HUMAN IGG SUBCLASSES RID COMBI KIT (MODIFICATION) (K943205)

_Research Diagnostics, Inc. · DAS · Sep 7, 1994 · Immunology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DAS/K943205

## Device Facts

- **Applicant:** Research Diagnostics, Inc.
- **Product Code:** [DAS](/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DAS.md)
- **Decision Date:** Sep 7, 1994
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 866.5530
- **Device Class:** Class 1
- **Review Panel:** Immunology

## Regulatory Identification

An immunoglobulin G (Fc fragment specific) immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the Fc (carbohydrate containing) fragment of immunoglobulin G (resulting from breakdown of immunoglobulin G antibodies) in urine, serum, and other body fluids. Measurement of immunoglobulin G Fc fragments aids in the diagnosis of plasma cell antibody-forming abnormalities, e.g., gamma heavy chain disease.

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**Source:** [https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DAS/K943205](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DAS/K943205)

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