← Product Code [DAS](/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DAS) · K895600

# HUMAN (IGG) SUBCLASS (EIA) KIT (K895600)

_The Binding Site, Ltd. · DAS · Nov 8, 1989 · Immunology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DAS/K895600

## Device Facts

- **Applicant:** The Binding Site, Ltd.
- **Product Code:** [DAS](/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DAS.md)
- **Decision Date:** Nov 8, 1989
- **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/K895600](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DAS/K895600)

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