Browse hierarchy: [Immunology (IM)](/submissions/IM) → [Subpart F — Immunological Test Systems](/submissions/IM/subpart-f%E2%80%94immunological-test-systems) → [21 CFR 866.5210](/submissions/IM/subpart-f%E2%80%94immunological-test-systems/866.5210) → CHN — Immunochemical, Ceruloplasmin

# CHN · Immunochemical, Ceruloplasmin

_Immunology · 21 CFR 866.5210 · Class 2_

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

## Overview

- **Product Code:** CHN
- **Device Name:** Immunochemical, Ceruloplasmin
- **Regulation:** [21 CFR 866.5210](/submissions/IM/subpart-f%E2%80%94immunological-test-systems/866.5210)
- **Device Class:** 2
- **Review Panel:** [Immunology](/submissions/IM)

## Identification

A ceruloplasmin immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the ceruloplasmin (copper-transporting serum protein) in serum, other body fluids, or tissues. Measurements of ceruloplasmin aid in the diagnosis of copper metabolism disorders.

## Classification Rationale

Class II (special 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.

## Special Controls

*Classification.* Class II (special 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 (3 of 3)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K091741](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/CHN/K091741.md) | TINA-QUANT CERULOPLASMIN | Roche Diagnostics | Mar 18, 2010 | SESE |
| [K063655](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/CHN/K063655.md) | DIMENSION VISTA; CER FLEX REAGENT CARTRIDGE, PROTEIN 1 CALIBRATOR, PROTEIN 1 CONTROL MEDIUM, PROTEIN 1 CONTROL HIGH | Dade Behring, Inc. | Feb 15, 2007 | SESE |
| [K062114](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/CHN/K062114.md) | CERULOPLASMIN, MODEL 2055953 | Roche Diagnostics Corp. | Jan 31, 2007 | SESE |

## Top Applicants

- Roche Diagnostics Corp. — 1 clearance
- Roche Diagnostics — 1 clearance
- Dade Behring, Inc. — 1 clearance

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

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