Chromogenic Factor VIII Assay FDA-Cleared

On Monday, July 20, Fritsma Factor sponsor Precision BioLogic Inc. announced  US FDA 510[k] clearance of their CRYOcheck™ Chromogenic Factor VIII assay. The assay had been previously approved in Canada, the European Union, Australia, and New Zealand. The assay boasts a test range from 0–200% FVIII using one standard curve and a limit of quantitation below 1%. Click here for Precision’s press release.

In August, Precision BioLogic will be hosting a free online webinar to review the benefits of chromogenic factor VIII testing and highlight the new CRYOcheck™ Chromogenic Factor VIII assay. To be notified of webinar details, sign up at www.precisionbiologic.com/webinar. We look forward to connecting with you at the webinar.