Sysmex America receives FDA clearance for CN-6000™ hemostasis analyzer
Chicago, June 25, 2025 – Sysmex America, Inc., a leading provider of diagnostic solutions for hematology, hemostasis, urinalysis, flow cytometry, and informatics, has received U.S. Food and Drug Administration (FDA) clearance for the CN-6000™ automated hemostasis analyzer. The clearance includes reagents for five common hemostasis tests: Prothrombin Time (PT) and PT INR with Dade® Innovin®, Activated Partial Thromboplastin Time (APTT) with Dade® Actin® FSL, Fibrinogen (Fbg) with Dade® Thrombin Reagent, Antithrombin (AT) with INNOVANCE® Antithrombin, and D-Dimer with INNOVANCE® D-Dimer. “Our hemostasis solutions combine advanced technology, reliable reagents, and award-winning service to provide laboratories with accurate results for diagnosing bleeding or clotting disorders,” said Dan Zortman, CEO of Sysmex America. The CN-6000™ offers high throughput and fully automated testing in a space-saving design that can be adapted to the needs of various laboratories. An optional sample loader with expandable capacity is available for high-volume laboratories.…
