Browse hierarchy: [Immunology (IM)](/submissions/IM) → [Subpart F — Immunological Test Systems](/submissions/IM/subpart-f%E2%80%94immunological-test-systems) → [21 CFR 866.5230](/submissions/IM/subpart-f%E2%80%94immunological-test-systems/866.5230) → DGJ — Colostrum, Antigen, Antiserum, Control

# DGJ · Colostrum, Antigen, Antiserum, Control

_Immunology · 21 CFR 866.5230 · Class 1_

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

## Overview

- **Product Code:** DGJ
- **Device Name:** Colostrum, Antigen, Antiserum, Control
- **Regulation:** [21 CFR 866.5230](/submissions/IM/subpart-f%E2%80%94immunological-test-systems/866.5230)
- **Device Class:** 1
- **Review Panel:** [Immunology](/submissions/IM)

## Identification

A colostrum immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the specific proteins in colostrum. Colostrum is a substance excreted by the mammary glands during pregnancy and until production of breast milk begins 1 to 5 days after childbirth.

## 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 the limitations in § 866.9.

## Recent Cleared Devices (1 of 1)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K890689](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DGJ/K890689.md) | ADX TM OPIATES | Abbott Laboratories | Aug 25, 1989 | SESE |

## Top Applicants

- Abbott Laboratories — 1 clearance

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

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