FDA Approves CRYOcheck Factor VIII Deficient Plasma with VWF

The U.S. Food and Drug Administration (FDA) has granted 510(k) clearance to Precision BioLogic’s CRYOcheck Factor VIII (FVIII) Deficient Plasma with von Willebrand factor (VWF), opening the pathway for the company to launch the product in the U.S. The treatment is designed to be used in clinical laboratories to identify human plasma with FVIII deficiency. CRYOcheck comes in a frozen format, which reduces preparation time and errors.

“Precision BioLogic provides tools to help laboratory professionals make the best decisions, faster,” says Paul Empey, the company’s president and CEO. “CRYOcheck factor VIII deficient plasma with VWF offers labs a readily available and reliable alternative to congenital FVIII deficient plasmas. In fact, the product has already gained significant traction within the hemophilia research and pharmaceutical manufacturing community.”