← Product Code [DBM](/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DBM) · K962452

# HY-TEC/MANUAL AUTOIMMUNE KIT FOR MITOCHONDRIA (K962452)

_Hycor Biomedical, Inc. · DBM · Nov 25, 1996 · Immunology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DBM/K962452

## Device Facts

- **Applicant:** Hycor Biomedical, Inc.
- **Product Code:** [DBM](/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DBM.md)
- **Decision Date:** Nov 25, 1996
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 866.5090
- **Device Class:** Class 2
- **Review Panel:** Immunology

## Regulatory Identification

An antimitochondrial antibody immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the antimitochondrial antibodies in human serum. The measurements aid in the diagnosis of diseases that produce a spectrum of autoantibodies (antibodies produced against the body's own tissue), such as primary biliary cirrhosis (degeneration of liver tissue) and chronic active hepatitis (inflammation of the liver).

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**Source:** [https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DBM/K962452](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DBM/K962452)

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