In Brief: Biopool
This article was originally published in The Gray Sheet
Executive Summary
Biopool: Receives FDA 510(k) clearance for its Spectrolyse Antithrombin-III (anti-Xa) Assay Kit for clinically testing a "patient's risk for developing blood clots." The kit measures plasma levels of Antithrombin-III, an inhibitor of enzymes that promote the formation of blood clots. Approval of the test expands Biopool's "line of in vitro products dedicated to assessing and diagnosing the risks of clotting and bleeding disorders," the company says...