Sysmex America Receives FDA Clearance for Automated Blood Coagulation Analyzer CN-Series CN-6000™

Chicago – June 25, 2025 – Sysmex America, Inc., a leading diagnostic solutions company offering hematology, hemostasis, urinalysis, flow cytometry and informatic solutions, has received FDA clearance for the CN-6000™ Automated Blood Coagulation Analyzer. This clearance includes the reagent products used in five commonly performed 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
• D-dimer with INNOVANCE® D-Dimer

“Sysmex’s hemostasis solutions bring together advanced technology, trusted reagents and award-winning service to provide laboratories with reliable results for diagnosing patients suffering from bleeding or clotting disorders,” said Dan Zortman, CEO of Sysmex America. “Sysmex America’s CN-Series, CN-6000 analyzer, provides high throughput and fully automated testing in a space-saving footprint, that is expandable to match the needs of different laboratories.”

Laboratories with high workloads may opt for the optional sampler that provides an expandable sample loading capacity.

Sysmex will continue efforts to obtain market authorization for the Automated Blood Coagulation Analyzer CN-3000 and additional reagent applications.

To learn more about Sysmex’s CN-6000 and other hemostasis products that are designed with quality and efficiency in mind, visit www.sysmex.com.

About Sysmex America
The combination of Sysmex America’s new testing methods and innovative hematology, hemostasis, urinalysis, flow cytometry and informatic systems are transforming the future of healthcare and contributing to healthier lives. As Americas regional affiliate of Kobe, Japan-based Sysmex Corporation – a trusted global leader respected for optimizing the efficiency, operations and financial performance of clinical laboratories – it offers diagnostic products that equip patients and the healthcare professionals who treat them with the information needed to make decisions with greater trust and confidence. Forbes magazine named Sysmex one of the most innovative companies in the healthcare equipment and services category, and the Center for Companies That Care named Sysmex America to its “Honor Roll.” Learn more about Sysmex America at www.sysmex.com/us.

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