← Product Code [DBI](/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DBI) · K890564

# SPQ(TM) ANTIBODY REAGENT SET II FOR C4 (K890564)

_Atlantic Antibodies · DBI · Feb 17, 1989 · Immunology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DBI/K890564

## Device Facts

- **Applicant:** Atlantic Antibodies
- **Product Code:** [DBI](/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DBI.md)
- **Decision Date:** Feb 17, 1989
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 866.5240
- **Device Class:** Class 2
- **Review Panel:** Immunology

## Regulatory Identification

A complement components immunological test system is a device that consists of the reagents used to measure by immunochemical techniques complement components C1q , C1r , C1s , C2 , C3 , C4 , C5 , C6 , C7 , C8 , and C9 , in serum, other body fluids, and tissues. Complement is a group of serum proteins which destroy infectious agents. Measurements of these proteins aids in the diagnosis of immunologic disorders, especially those associated with deficiencies of complement components.

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**Source:** [https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DBI/K890564](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DBI/K890564)

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