← Product Code [CGI](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CGI) · K781938

# RIA KIT, GAMMADAB ESTRIOL (K781938)

_Clinical Assays, Inc. · CGI · Jan 10, 1979 · Clinical Chemistry · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CGI/K781938

## Device Facts

- **Applicant:** Clinical Assays, Inc.
- **Product Code:** [CGI](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CGI.md)
- **Decision Date:** Jan 10, 1979
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 862.1265
- **Device Class:** Class 1
- **Review Panel:** Clinical Chemistry

## Regulatory Identification

An estriol test system is a device intended to measure estriol, an estrogenic steroid, in plasma, serum, and urine of pregnant females. Estriol measurements are used in the diagnosis and treatment of fetoplacental distress in certain cases of high-risk pregnancy.

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**Source:** [https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CGI/K781938](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CGI/K781938)

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