Browse hierarchy: [Immunology (IM)](/submissions/IM) → [Subpart F — Immunological Test Systems](/submissions/IM/subpart-f%E2%80%94immunological-test-systems) → [21 CFR 866.5160](/submissions/IM/subpart-f%E2%80%94immunological-test-systems/866.5160) → DCJ — Beta-Globulin, Antigen, Antiserum, Control

# DCJ · Beta-Globulin, Antigen, Antiserum, Control

_Immunology · 21 CFR 866.5160 · Class 1_

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

## Overview

- **Product Code:** DCJ
- **Device Name:** Beta-Globulin, Antigen, Antiserum, Control
- **Regulation:** [21 CFR 866.5160](/submissions/IM/subpart-f%E2%80%94immunological-test-systems/866.5160)
- **Device Class:** 1
- **Review Panel:** [Immunology](/submissions/IM)

## Identification

A beta-globulin immunological test system is a device that consists of reagents used to measure by immunochemical techniques beta globulins (serum protein) in serum and other body fluids. Beta-globulin proteins include beta-lipoprotein, transferrin, glycoproteins, and complement, and are rarely associated with specific pathologic disorders.

## 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 |
| --- | --- | --- | --- | --- |
| [K891093](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DCJ/K891093.md) | ACA (R) DIGITOXIN CALIBRATOR | E.I. Dupont DE Nemours & Co., Inc. | Apr 26, 1989 | SESE |

## Top Applicants

- E.I. Dupont DE Nemours & Co., Inc. — 1 clearance

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

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