← Product Code [MOB](/submissions/IM/subpart-f%E2%80%94immunological-test-systems/MOB) · K954105

# EIA KIT FOR THE DETCTION OF ANTI-PR3 ANTIBODIES (K954105)

_Scimedx Corp. · MOB · Mar 19, 1996 · Immunology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/MOB/K954105

## Device Facts

- **Applicant:** Scimedx Corp.
- **Product Code:** [MOB](/submissions/IM/subpart-f%E2%80%94immunological-test-systems/MOB.md)
- **Decision Date:** Mar 19, 1996
- **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/MOB/K954105](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/MOB/K954105)

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