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) → DFZ — Igg (Gamma Chain Specific), Antigen, Antiserum, Control

# DFZ · Igg (Gamma Chain Specific), 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/DFZ

## Overview

- **Product Code:** DFZ
- **Device Name:** Igg (Gamma Chain Specific), 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 (9 of 9)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K092283](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DFZ/K092283.md) | DIMENSION VISTA IMMUNOGLOBULIN IGG SUBCLASSS 1FLEX REAGENT CARTRIDGE, DIMENSION VISTA IMMUNOGLOBULIN IGG | Siemens Healthcare Diagnostics | Oct 21, 2009 | SESE |
| [K021081](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DFZ/K021081.md) | HUMAN IGG SUBCLASS LIQUID REAGENT KITS FOR USE ON THE HITACHI 911/7070 TURBIDIMETRIC ANALYSER | The Binding Site, Ltd. | Jun 17, 2002 | SESE |
| [K020823](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DFZ/K020823.md) | PELICLASS HUMAN IGG SUBCLASS NEPHELOMETRIC IMMAGE KIT | Sanquin Blood Supply Foundation | May 14, 2002 | SESE |
| [K955906](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DFZ/K955906.md) | BOEHRINGER MANNHEIM IGG ASSAY | Boehringer Mannheim Corp. | Feb 9, 1996 | SESE |
| [K940422](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DFZ/K940422.md) | IGG SUBCLASS SINGLE DILUTION DIAGNOSTIC KIT FOR USE WITH THE BECKMAN ARRAY ANALYZER | The Binding Site, Ltd. | May 27, 1994 | SESE |
| [K812821](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DFZ/K812821.md) | H-103 IGG, H-104 IGA, H-105 IGM | Immulok, Inc. | Oct 26, 1981 | SESE |
| [K803272](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DFZ/K803272.md) | AUTOMATED IMMUNOPRECIPITIN METHOD/ICG | Icl Scientific | Jan 26, 1981 | SESE |
| [K790720](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DFZ/K790720.md) | ANTISERA TO RABBIT IMMUNOGLOBULIN | Kent Laboratories, Inc. | Aug 16, 1979 | SESE |
| [K790709](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DFZ/K790709.md) | ANTISERUM TO RABBIT IMMUNOGLOBULIN | Kent Laboratories, Inc. | Aug 16, 1979 | SESE |

## Top Applicants

- Kent Laboratories, Inc. — 2 clearances
- The Binding Site, Ltd. — 2 clearances
- Boehringer Mannheim Corp. — 1 clearance
- Icl Scientific — 1 clearance
- Immulok, Inc. — 1 clearance

---

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

**Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact).

**Cite:** Innolitics at https://innolitics.com