# MVD · System, Test, Her-2/Neu, Nucleic Acid Or Serum

_ ·  · Class 3_

**Canonical URL:** https://fda.innolitics.com/productcode/MVD

## Overview

- **Product Code:** MVD
- **Device Name:** System, Test, Her-2/Neu, Nucleic Acid Or Serum
- **Regulation:** 21 CFR N/A
- **Device Class:** 3
- **Review Panel:** [](/submissions/)

## Recent Cleared Devices (3 of 3)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [P040005](/device/P040005.md) | DAKOCYTOMATION HER2 FISH PHARMDX KIT | Agilent Technologies Singapore (International) Pte , Ltd. | May 3, 2005 | APPR |
| [P980024](/device/P980024.md) | PATHVYSION HER-2 DNA PROBE KIT | Abbott Molecular, Inc. | Dec 11, 1998 | APPR |
| [P940004](/device/P940004.md) | ONCOR(R) AMPLITECT(TM) HER/NEU(ERBB2)GENE AMPLIFI | Ventana Medical Systems, Inc. | Dec 30, 1997 | APWD |

## Top Applicants

- Abbott Molecular, Inc. — 1 clearance
- Agilent Technologies Singapore (International) Pte , Ltd. — 1 clearance
- Ventana Medical Systems, Inc. — 1 clearance

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**Source:** [https://fda.innolitics.com/productcode/MVD](https://fda.innolitics.com/productcode/MVD)

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