Browse hierarchy: [Immunology (IM)](/submissions/IM) → [Subpart F — Immunological Test Systems](/submissions/IM/subpart-f%E2%80%94immunological-test-systems) → [21 CFR 866.5510](/submissions/IM/subpart-f%E2%80%94immunological-test-systems/866.5510) → DAH — Gamma Globulin, Antigen, Antiserum, Control

# DAH · Gamma Globulin, Antigen, Antiserum, Control

_Immunology · 21 CFR 866.5510 · Class 2_

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

## Overview

- **Product Code:** DAH
- **Device Name:** Gamma Globulin, Antigen, Antiserum, Control
- **Regulation:** [21 CFR 866.5510](/submissions/IM/subpart-f%E2%80%94immunological-test-systems/866.5510)
- **Device Class:** 2
- **Review Panel:** [Immunology](/submissions/IM)
- **3rd-party reviewable:** yes

## Identification

An immunoglobulins A, G, M, D, and E immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the immunoglobulins A, G, M, D, an E (serum antibodies) in serum. Measurement of these immunoglobulins aids in the diagnosis of abnormal protein metabolism and the body's lack of ability to resist infectious agents.

## Classification Rationale

Class II (performance standards).

## Recent Cleared Devices (7 of 7)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K931247](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DAH/K931247.md) | TITAN GEL IMMUNOFIX-9 CAT. NO. 3051 AND 3067 | Helena Laboratories | Apr 27, 1993 | SESE |
| [K905149](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DAH/K905149.md) | TITAN GEL | Helena Laboratories | Jan 3, 1991 | SESE |
| [K901805](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DAH/K901805.md) | REP(R) IMMUNOFIX | Helena Laboratories | Jun 6, 1990 | SESE |
| [K884074](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DAH/K884074.md) | IMMUNOCHEMICAL DETERMINATION OF IMMUNOGLOBULIN G | Orion Diagnostica, Inc. | Oct 27, 1988 | SESE |
| [K883494](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DAH/K883494.md) | TECHNICON DPA-1 IMMUNOGLOBULIN G | Technicon Instruments Corp. | Sep 7, 1988 | SESE |
| [K854944](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DAH/K854944.md) | TDX IMMUNOGLOBULIN M DIAGNOSTIC KIT | Abbott Laboratories | Aug 27, 1986 | SESE |
| [K862184](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DAH/K862184.md) | DAKO ITA, IMMUNOGLOBULIN M (IGM) | Dako Corp. | Aug 19, 1986 | SESE |

## Top Applicants

- Helena Laboratories — 3 clearances
- Technicon Instruments Corp. — 1 clearance
- Orion Diagnostica, Inc. — 1 clearance
- Dako Corp. — 1 clearance
- Abbott Laboratories — 1 clearance

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

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