← Product Code [DDC](/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DDC) · K000363

# MODIFICATION TO ZEUS SCIENTIFIC, INC., THYROGLOBULIN IGG ELISA TEST SYSTEM (K000363)

_Zeus Scientific, Inc. · DDC · Feb 18, 2000 · Immunology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DDC/K000363

## Device Facts

- **Applicant:** Zeus Scientific, Inc.
- **Product Code:** [DDC](/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DDC.md)
- **Decision Date:** Feb 18, 2000
- **Decision:** SESE
- **Submission Type:** Special
- **Regulation:** 21 CFR 866.5870
- **Device Class:** Class 2
- **Review Panel:** Immunology

## Regulatory Identification

A thyroid autoantibody immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the thyroid autoantibodies (antibodies produced against the body's own tissues). Measurement of thyroid autoantibodies may aid in the diagnosis of certain thyroid disorders, such as Hashimoto's disease (chronic lymphocytic thyroiditis), nontoxic goiter (enlargement of thyroid gland), Grave's disease (enlargement of the thyroid gland with protrusion of the eyeballs), and cancer of the thyroid.

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**Source:** [https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DDC/K000363](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DDC/K000363)

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