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) → CZJ — Igd, Antigen, Antiserum, Control

# CZJ · Igd, 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/CZJ

## Overview

- **Product Code:** CZJ
- **Device Name:** Igd, 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 (8 of 8)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K092450](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/CZJ/K092450.md) | HUMAN IGD KIT FOR USE ON SPAPLUS | The Binding Site | Dec 28, 2009 | SESE |
| [K051299](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/CZJ/K051299.md) | IGD DIAGNOSTIC TEST KITS | The Binding Site, Ltd. | Nov 23, 2005 | SESE |
| [K002561](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/CZJ/K002561.md) | SHEEP ANTI-HUMAN IGD IMMUNOFIXATION GRADE KIT | The Binding Site, Ltd. | Oct 26, 2000 | SESE |
| [K913671](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/CZJ/K913671.md) | HUMAN IGD IMMUNOLOGICAL NL TEST KIT | The Binding Site, Ltd. | Dec 2, 1991 | SESE |
| [K883001](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/CZJ/K883001.md) | QM300 CALIBRATOR D PACK | Kallestad Diag, A Div. of Erbamont, Inc. | Sep 22, 1988 | SESE |
| [K872834](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/CZJ/K872834.md) | TITAN GEL IFE ANTISERUM TO IGD-9409 & IGE-9410 | Helena Laboratories | Aug 12, 1987 | SESE |
| [K831956](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/CZJ/K831956.md) | DETERM. SIZE 72 RADIAL-HUMAN IGD | Kent Laboratories, Inc. | Jul 18, 1983 | SESE |
| [K772327](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/CZJ/K772327.md) | LAS-R HUMAN IGD TEST | Hyland Therapeutic Div., Travenol Laboratories | Feb 28, 1978 | SESE |

## Top Applicants

- The Binding Site, Ltd. — 3 clearances
- Helena Laboratories — 1 clearance
- Hyland Therapeutic Div., Travenol Laboratories — 1 clearance
- Kallestad Diag, A Div. of Erbamont, Inc. — 1 clearance
- Kent Laboratories, Inc. — 1 clearance

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

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