PBI FVIII Inhibitor Kit Approved

PBI FVIII Inhibitor Kit Approved
Mar 24, 2019 2:24pm

On March 13, 2019, Precision BioLogic Inc. announced US FDA clearance for the new CRYOcheck Factor VIII Inhibitor Kit. Click or tap here for the complete news release. This clearance follows approvals received from regulatory authorities in Canada, the European Union, Australia, and New Zealand, where the kit launched in February of this year. The kit contains standardized components and a validated procedure to prepare patient samples for performing a modified Nijmegen-Bethesda assay as per the U.S.-based Centers for Disease Control and Prevention (CDC ) recommendation.

0 Comments

On March 13, 2019, Precision BioLogic Inc. announced US FDA clearance for the new CRYOcheck Factor VIII Inhibitor Kit. Click or tap here for the complete news release. This clearance follows approvals received from regulatory authorities in Canada, the European Union, Australia, and New Zealand, where the kit launched in February of this year. The kit contains standardized components and a validated procedure to prepare patient samples for performing a modified Nijmegen-Bethesda assay as per the U.S.-based Centers for Disease Control and Prevention (CDC ) recommendation.

Leave A Comment

You must be logged in to Comment - Sign In