Precision BioLogic, a leading developer of hemostasis diagnostic products, is pleased to announce FDA 510(k) clearance and the launch of its new CRYOcheck Chromogenic Factor VIII assay in the U.S. This clearance follows authorizations received from regulatory authorities in Canada, the European Union, Australia, and New Zealand where the assay launched earlier this year.
CRYOcheck Chromogenic Factor VIII is intended for use by clinical labs for the determination of...