← Product Code [DFF](/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DFF) · K863868

# IMMUNO-PLATE IV RADIAL IMMUNO TEST KIT/ALPHA-1 ANT (K863868)

_Cooper Biomedical, Inc. · DFF · Feb 13, 1987 · Immunology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DFF/K863868

## Device Facts

- **Applicant:** Cooper Biomedical, Inc.
- **Product Code:** [DFF](/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DFF.md)
- **Decision Date:** Feb 13, 1987
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 866.5080
- **Device Class:** Class 2
- **Review Panel:** Immunology

## Regulatory Identification

An alpha -1-antichymotrypsin immunological test system is a device that consists of the reagents used to measure by immunochemical techniques alpha -1-antichymotrypsin (a protein) in serum, other body fluids, and tissues. Alpha -1-antichymotrypsin helps protect tissues against proteolytic (protein-splitting) enzymes released during infection.

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**Source:** [https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DFF/K863868](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DFF/K863868)

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