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VENTANA HER2 Dual ISH DNA Probe Cocktail

FDA PMA

Class III (US FDA PMA)

PMA P190031

by Ventana Medical Systems, Inc.

Identity

Trade Name
HER2 Dual ISH DNA Probe Cocktail FDA PMA
Generic Name
Chromogenic in situ hybridization, nucleic acid amplification, HER2/NEU gene, breast cancer FDA PMA

Identifiers

PMA Number
P190031 FDA PMA
FDA Product Code
NYQ FDA PMA

Classification

Device Class
Class III FDA PMA
Advisory Committee
Pathology FDA PMA
FDA Decision
APPR Approved FDA PMA

The VENTANA HER2 Dual ISH DNA Probe Cocktail is a chromogenic in situ hybridization, nucleic acid amplification assay designed for the detection of the HER2/NEU gene in breast cancer tissue. It is classified under device class 3 and is intended for use in pathology laboratories as part of diagnostic testing for HER2 status.

This assay is supplied as a reagent cocktail for use on the VENTANA BenchMark series of automated staining systems. It is for in vitro diagnostic use only, requires professional handling, and is regulated under FDA PMA approval (P190031). The product is not sterile, not MRI conditional, and is intended for single-use in clinical pathology settings.

Frequently asked questions

What is the VENTANA HER2 Dual ISH DNA Probe Cocktail used for?

The VENTANA HER2 Dual ISH DNA Probe Cocktail is used for the detection of the HER2/NEU gene in breast cancer tissue through chromogenic in situ hybridization and nucleic acid amplification, as specified in its device classification and intended use within pathology diagnostics.

Is the VENTANA HER2 Dual ISH DNA Probe Cocktail approved for clinical use?

Yes, the VENTANA HER2 Dual ISH DNA Probe Cocktail received FDA PMA approval (P190031) on July 28, 2020, as stated in the device data under decision code APPR and decision date 2020-07-28, confirming its regulatory authorization for in vitro diagnostic use.

Who manufactures the VENTANA HER2 Dual ISH DNA Probe Cocktail?

The VENTANA HER2 Dual ISH DNA Probe Cocktail is manufactured by VENTANA Medical Systems, Inc., located in Tucson, Arizona, as indicated in the manufacturer and address fields of the device data.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: VENTANA® anti-HER2/neu (4B5) Rabbit Monoclonal Primary Antibody, Home | Ventana

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_PMA

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Manufacturer

Manufacturer
Ventana Medical Systems, Inc.

Sources (1)

  • FDA PMA P190031 24 fields · synced Oct 6, 2026