← Product Code [DBF](/productcode/DBF) · K801676

# FERRIZYME  FERRITIN ENZYME IMMUNOASSAY (K801676)

_Abbott Laboratories · DBF · Aug 20, 1980 · Immunology · SESE_

**Canonical URL:** https://fda-staging.innolitics.com/device/K801676

## Device Facts

- **Applicant:** Abbott Laboratories
- **Product Code:** [DBF](/productcode/DBF.md)
- **Decision Date:** Aug 20, 1980
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 866.5340
- **Device Class:** Class 2
- **Review Panel:** Immunology

## Regulatory Identification

A ferritin immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the ferritin (an iron-storing protein) in serum and other body fluids. Measurements of ferritin aid in the diagnosis of diseases affecting iron metabolism, such as hemochromatosis (iron overload) and iron deficiency amemia.

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**Source:** [https://fda-staging.innolitics.com/device/K801676](https://fda-staging.innolitics.com/device/K801676)

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