Industry Press Releases

Hycor Biomedical receives 510 (k) from the FDA for a modern NOVEOS ™ allergy testing tool

Thursday, Dec 20, 2018

Hycor Biomedical, a leading manufacturer of in vitro diagnostic tools for testing allergies and autoimmune diseases, today announced that it has obtained a 510 (k) approval from the US Food and Drug Administration (FDA) to sell the new NOVEOS allergy testing system.

"Hycor has been at the forefront of allergy testing for many years, and NOVEOS is a novelty that completely changes the paradigm of diagnostic systems in laboratories with limited allergies," said Dr. Fei Li , President and CEO of Hycor. sales of NOVEOS underline our commitment to trigger the immunodiagnosis of allergies towards the 21st century, and this applies equally to patients, laboratories and doctors. "

NOVEOS works with microparticles, chemiluminescence and ready solutions. This is the first technology of its kind in the field of daily allergy testing over the next 20 years. The system is primarily intended to help address the current problems of laboratories related to current technologies by offering a range of innovative features such as significant reduction in sample size, reduction of blood-related interferences, lower variability within allergen groups, higher accuracy and more time for professional work laboratory technicians.

At the same time, the company has been authorized to sell the first IgE-specific IgE (sIgE) test system to detect mite allergens (D001) and is currently developing another test to offer its customers a complete menu.

"This new IgE antibody microbe assay technology looks very promising and has the potential to become a new diagnostic option with the unique requirements of a small sample to identify susceptibility in patients with suspected allergies," said Robert G. Hamilton , PhD., D.ABMLI, Professor of Medicine and Pathology at the Johns Hopkins University Medical School.

About Hycor Biomedical
Hycor was established in 1981 and has become a global manufacturer and retailer of in vitro diagnostic tools. Since its inception, it has entered the field of allergies and autoimmunities, and its products are being used in clinical laboratories, hospitals, and physician offices around the world. Its products include brand HYTEC ® and AUTOSTACH ® and recently entered the market and product line NOVEOS, which received CE mark for sale within the European Union, as well as permission from the FDA within the United States . The company focuses on providing high quality products offering the highest value to clinical staff based on innovation, reliability and customer service. For more information, please


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