← Product Code [DFB](/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DFB) · K823829

# FERRITIN IMMUNORADIOMETRIC ASSAY KIT (K823829)

_Bd Becton Dickinson Vacutainer Systems Preanalytic · DFB · Mar 11, 1983 · Immunology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-f%E2%80%94immunological-test-systems/DFB/K823829

## Device Facts

- **Applicant:** Bd Becton Dickinson Vacutainer Systems Preanalytic
- **Product Code:** [DFB](/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DFB.md)
- **Decision Date:** Mar 11, 1983
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 866.5130
- **Device Class:** Class 2
- **Review Panel:** Immunology

## Regulatory Identification

An alpha-1-antitrypsin immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the alpha-1-antitrypsin (a plasma protein) in serum, other body fluids, and tissues. The measurements aid in the diagnosis of several conditions including juvenile and adult cirrhosis of the liver. In addition, alpha-1-antitrypsin deficiency has been associated with pulmonary emphysema.

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**Source:** [https://fda.innolitics.com/submissions/CH/subpart-f%E2%80%94immunological-test-systems/DFB/K823829](https://fda.innolitics.com/submissions/CH/subpart-f%E2%80%94immunological-test-systems/DFB/K823829)

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