Jul 21 2020
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 […]
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