July 2025—Sysmex America has received FDA clearance for its CN-6000 automated blood coagulation analyzer. The clearance also covers reagent products for prothrombin time seconds and PT INR (Dade Innovin), activated partial thromboplastin time (Dade Actin FSL), fibrinogen (Dade thrombin reagent), antithrombin (Innovance antithrombin), and D-dimer (Innovance D-dimer). Sysmex has also received Health Canada license for the CN-6000 as well as its CN-3000 automated blood coagulation analyzer.
Sysmex America, 888-879-7639