← Product Code [DEX](/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DEX) · K823765

# ANTI SERA TO HUMAN OROSCOMUCOID (K823765)

_Kent Laboratories, Inc. · DEX · Dec 30, 1982 · Immunology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DEX/K823765

## Device Facts

- **Applicant:** Kent Laboratories, Inc.
- **Product Code:** [DEX](/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DEX.md)
- **Decision Date:** Dec 30, 1982
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 866.5420
- **Device Class:** Class 1
- **Review Panel:** Immunology

## Regulatory Identification

An alpha-1-glycoproteins immunological test system is a device that consists of the reagents used to measure by immunochemical techniques alpha-1-glycoproteins (a group of plasma proteins found in the alpha-1 group when subjected to electrophoresis) in serum and other body fluids. Measurement of specific alpha-1-glycoproteins may aid in the diagnosis of collagen (connective tissue) disorders, tuberculosis, infections, extensive malignancy, and diabetes.

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**Source:** [https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DEX/K823765](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DEX/K823765)

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