We are excited to share that NewBio has successfully passed our QMS recertification audit, resulting in the renewal of our ISO 13485 and MDSAP certifications, now valid until 2027. Alongside our IVDR certification for TPHA and RPR products, this milestone reaffirms our commitment to delivering high-quality diagnostic products. These certifications not only ensure compliance with EU and UK standards but also demonstrate that our QMS meets regulatory requirements in Australia, the US, and Canada, providing our customers with continued confidence in our products and services.
Read More »We're proud to announce the IVDR-compliant Newmarket Biomedical TPHA Kits NB007 (100), NB008 (200), and NB009 (1000) have recently been granted approval to expand its intended use to include CSF, making it an essential tool for every clinical lab. The only commercially available IVDR compliant TPHA kit across Europe capable of testing with CSF.
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