Firalis SA - FDA 510(k) Cleared Devices

Firalis SA, is a European biomarker and diagnostic company founded in 2008, with a manufacturing facility in Huningue, France. The company specializes in innovative Immunology devices and clinical diagnostic solutions, including ELISA kits, recombinant proteins, monoclonal antibodies, and biobanked clinical samples.

Firalis has submitted 1 FDA 510(k) application focused on Immunology devices. The company received 0 FDA 510(k) clearance in 2025. This represents the company's regulatory engagement with the U.S. market in the immunology device category.

The company operates a quality biobank certified under the French standard NF S96-900, maintaining clinical samples from cardiovascular, neurodegenerative, and rheumatology studies. Firalis has secured over 20 million euros in European research grants and collaborative funding, supporting its R&D portfolio and IP development across multiple therapeutic areas.

Explore the company's device submissions, product codes, and clearance details in the database records below.