← Product Code [DAC](/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DAC) · K771583

# FLUORESCENT ANTI. ANTI-HUMAN C3 (K771583)

_Burroughs Wellcome Co. · DAC · Sep 2, 1977 · Immunology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/MI/subpart-f%E2%80%94immunological-test-systems/DAC/K771583

## Device Facts

- **Applicant:** Burroughs Wellcome Co.
- **Product Code:** [DAC](/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DAC.md)
- **Decision Date:** Sep 2, 1977
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 866.5260
- **Device Class:** Class 2
- **Review Panel:** Immunology

## Regulatory Identification

A complement C3b inactivator immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the complement C3b inactivator (a plasma protein) in serum. Complement is a group of serum proteins that destroy infectious agents. Measurement of complement C3b inactivator aids in the diagnosis of inherited antibody dysfunction.

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**Source:** [https://fda.innolitics.com/submissions/MI/subpart-f%E2%80%94immunological-test-systems/DAC/K771583](https://fda.innolitics.com/submissions/MI/subpart-f%E2%80%94immunological-test-systems/DAC/K771583)

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