← Product Code [DBF](/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DBF) · K905770

# CIBA CORNING ACS FERRITIN IMMUNOASSAY (K905770)

_Ciba Corning Diagnostics Corp. · DBF · Mar 12, 1991 · Immunology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DBF/K905770

## Device Facts

- **Applicant:** Ciba Corning Diagnostics Corp.
- **Product Code:** [DBF](/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DBF.md)
- **Decision Date:** Mar 12, 1991
- **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.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DBF/K905770](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DBF/K905770)

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