Ventana Medical Systems, Inc. - FDA 510(k) Cleared Devices

Ventana Medical Systems, Inc. specializes in immunohistochemical staining reagents and antibody-based diagnostic solutions, with a manufacturing facility in Tucson, Arizona. The company develops primary antibodies and prediluted reagents for pathology laboratories and immunology applications.

Ventana has received 46 FDA 510(k) clearances from 48 total submissions since 1992, establishing a strong regulatory track record in immunology devices. The company remains active, with its most recent clearance in 2024, demonstrating continued innovation in antibody-based diagnostic products.

The company's cleared devices focus on immunohistochemical detection and tissue analysis, including primary antibodies targeting cell markers such as CD45, CD20, CD4, S100, and melanoma-associated antigens. These reagents support pathology workflows in cancer diagnosis, immune cell identification, and tissue characterization.

Explore the complete list of cleared device names, product codes, and clearance dates in the 510(k) database.

510(k) submissions have been managed by Ventana Medical Systems, Inc. as regulatory consultant.