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The agency granted the treatment with 510(k) clearance.
The FDA granted 510(k) clearance to BioLogic’s CRYOcheck Factor VIII Deficient Plasma with VWF. This opens the pathway for the company to launch the product in the US.
"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."
The treatment is designed to be used in clinical laboratories to identify human plasma with factor VIII deficiency. CRYOcheck comes in a frozen format, which reduces preparation time and errors.
It has already launched in Canada, the EU, UK, Australia, and New Zealand.
(Sept. 18, 2023); PR Newswire; Precision BioLogic's Factor VIII Deficient Plasma with VWF Now FDA-Cleared for Sale in U.S.; https://www.prnewswire.com/news-releases/precision-biologics-factor-viii-deficient-plasma-with-vwf-now-fda-cleared-for-sale-in-us-301930398.html