← Product Code [DBL](/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DBL) · K944191

# ANTI-NUCLEAR ANTIBODY(ANA) TEST KIT W/MOUSE LIVER (K944191)

_Light Diagnostics · DBL · Mar 6, 1995 · Immunology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DBL/K944191

## Device Facts

- **Applicant:** Light Diagnostics
- **Product Code:** [DBL](/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DBL.md)
- **Decision Date:** Mar 6, 1995
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 866.5660
- **Device Class:** Class 2
- **Review Panel:** Immunology

## Regulatory Identification

A multiple autoantibodies immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the autoantibodies (antibodies produced against the body's own tissues) in serum and other body fluids. Measurement of multiple autoantibodies aids in the diagnosis of autoimmune disorders (disease produced when the body's own tissues are injured by autoantibodies).

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**Source:** [https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DBL/K944191](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DBL/K944191)

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