← Product Code [DBL](/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DBL) · K820088

# AFT SYSTEM PROFICIENCY TESTING PROGRAM (K820088)

_Calbiochem-Behring Corp. · DBL · Jan 26, 1982 · Immunology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DBL/K820088

## Device Facts

- **Applicant:** Calbiochem-Behring Corp.
- **Product Code:** [DBL](/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DBL.md)
- **Decision Date:** Jan 26, 1982
- **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/K820088](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DBL/K820088)

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