Certified partner for any assay development.
Whether you need highly specialized knowledge or manpower to bring your concept to market, we are your trusted independent partner for the development of many different types of immunoassays, with different technologies, either manually or automated. We are ISO 13485 certified and boast our own FDA registered manufacturing facility, offering small to medium scale pilot and commercial production capabilities. Immunoassays, point-of- care (POC) tests or validation services – you can expect superior performance.

Proven development approach: quality, conformity and transparency
To ensure highest quality, conformity and transparency, we apply our proven New Product Development Process to all assay development. Naturally, EN 13612:2002 and EN ISO 23640:2015 requirements and applicable CLSI guidelines are incorporated in this process, as is writing part of the technical file you need for IVD registration. Throughout the project, our dedicated expert team will involve you on a regular basis, and you can also monitor progress real-time – in SharePoint.

More skills, more speed, more success
Supply chain globalization, increasing pressure on costs and time to market, and ever-higher quality expectations by customers are challenges that companies face. To stay ahead in today’s IVD medical device market you need a specialized partner that is up for the challenge. We have the skills, the experience and the drive to help you deliver your assay to market rapidly and successfully.

STAT-IntraOperative-Intact-PTH Immunoassay Kit