Browse hierarchy: [Immunology (IM)](/submissions/IM) → [Subpart F — Immunological Test Systems](/submissions/IM/subpart-f%E2%80%94immunological-test-systems) → [21 CFR 866.5425](/submissions/IM/subpart-f%E2%80%94immunological-test-systems/866.5425) → DEF — Alpha-2-Hs-Glycoprotein, Antigen, Antiserum, Control

# DEF · Alpha-2-Hs-Glycoprotein, Antigen, Antiserum, Control

_Immunology · 21 CFR 866.5425 · Class 1_

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

## Overview

- **Product Code:** DEF
- **Device Name:** Alpha-2-Hs-Glycoprotein, Antigen, Antiserum, Control
- **Regulation:** [21 CFR 866.5425](/submissions/IM/subpart-f%E2%80%94immunological-test-systems/866.5425)
- **Device Class:** 1
- **Review Panel:** [Immunology](/submissions/IM)

## Identification

An alpha-2-glycoproteins immunolgical test system is a device that consists of the reagents used to measure by immunochemical techniques the alpha-2-glycoproteins (a group of plasma proteins found in the alpha-2 group when subjected to electrophoresis) in serum and other body fluids. Measurement of alpha-2-glycoproteins aids in the diagnosis of some cancers and genetically inherited deficiencies of these plasma proteins.

## Classification Rationale

Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 866.9.

## Recent Cleared Devices (1 of 1)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K924186](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DEF/K924186.md) | LPIA-FERRITIN ASSAY | Seradyn, Inc. | Dec 23, 1992 | SESE |

## Top Applicants

- Seradyn, Inc. — 1 clearance

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

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