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) → CZN — Iga, Fitc, Antigen, Antiserum, Control

# CZN · Iga, Fitc, 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/CZN

## Overview

- **Product Code:** CZN
- **Device Name:** Iga, Fitc, 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 |
| --- | --- | --- | --- | --- |
| [K891683](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/CZN/K891683.md) | TITAN GEL IFE FREE KAPPA/LAMBA LIGHT CHAIN ANTISER | Helena Laboratories | Apr 12, 1989 | SESE |
| [K855011](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/CZN/K855011.md) | QUANTIMETRIC PLUS C3 REAGENT KIT | Kallestad Laboratories, Inc. | Feb 26, 1986 | SESE |
| [K841815](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/CZN/K841815.md) | OPTIMATE IGA TEST | Miles Laboratories, Inc. | Jun 1, 1984 | SESE |
| [K832262](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/CZN/K832262.md) | FITC GOAT ANTI-HUMAN IMMUNOGLOBULINS | Gelco Diagnostics, Inc. | Oct 31, 1983 | SESE |
| [K832257](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/CZN/K832257.md) | GOAT ANTI-HUMAN IGA A CHAIN SPECIFIC | Gelco Diagnostics, Inc. | Oct 28, 1983 | SESE |
| [K831909](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/CZN/K831909.md) | RABBIT ANTISERUM TO HUMAN IGA | Dako Corp. | Jul 18, 1983 | SESE |
| [K831607](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/CZN/K831607.md) | FIAX IGA TEST KIT | Intl. Diagnostic Technology | Jun 22, 1983 | SESE |

## Top Applicants

- Gelco Diagnostics, Inc. — 2 clearances
- Dako Corp. — 1 clearance
- Helena Laboratories — 1 clearance
- Intl. Diagnostic Technology — 1 clearance
- Kallestad Laboratories, Inc. — 1 clearance

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

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