← Product Code [CHP](/productcode/CHP) · K841947

# ESTRADIOL DIRECT RADIOIMMUNOASSAY KIT (K841947)

_Sorin Biomedica, Fiat, USA, Inc. · CHP · Jun 25, 1984 · Clinical Chemistry · SESE_

**Canonical URL:** https://fda.innolitics.com/device/K841947

## Device Facts

- **Applicant:** Sorin Biomedica, Fiat, USA, Inc.
- **Product Code:** [CHP](/productcode/CHP.md)
- **Decision Date:** Jun 25, 1984
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 862.1260
- **Device Class:** Class 1
- **Review Panel:** Clinical Chemistry

## Regulatory Identification

An estradiol test system is a device intended to measure estradiol, an estrogenic steroid, in plasma. Estradiol measurements are used in the diagnosis and treatment of various hormonal sexual disorders and in assessing placental function in complicated pregnancy.

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**Source:** [https://fda.innolitics.com/device/K841947](https://fda.innolitics.com/device/K841947)

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