← Product Code [DGR](/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DGR) · K961544

# QUALITROL IGAME CONTROLS, LEVELS 1 AND 2 (K961544)

_Consolidated Technologies, Inc. · DGR · Sep 24, 1996 · Immunology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DGR/K961544

## Device Facts

- **Applicant:** Consolidated Technologies, Inc.
- **Product Code:** [DGR](/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DGR.md)
- **Decision Date:** Sep 24, 1996
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 866.5700
- **Device Class:** Class 1
- **Review Panel:** Immunology

## Regulatory Identification

A whole human plasma or serum immunological test system is a device that consists of reagents used to measure by immunochemical techniques the proteins in plasma or serum. Measurements of proteins in plasma or serum aid in the diagnosis of any disease concerned with abnormal levels of plasma or serum proteins, e.g., agammaglobulinemia, allergies, multiple myeloma, rheumatoid vasculitis, or hereditary angioneurotic edema.

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**Source:** [https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DGR/K961544](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DGR/K961544)

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