← Product Code [DEM](/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DEM) · K920005

# IL TEST ALPHA-1-ANTITRYPSIN (AAT) (K920005)

_Instrumentation Laboratory CO · DEM · Jul 29, 1992 · Immunology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DEM/K920005

## Device Facts

- **Applicant:** Instrumentation Laboratory CO
- **Product Code:** [DEM](/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DEM.md)
- **Decision Date:** Jul 29, 1992
- **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/IM/subpart-f%E2%80%94immunological-test-systems/DEM/K920005](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DEM/K920005)

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