Summary:
Sysmex America has received FDA clearance for its CN-6000 Automated Blood Coagulation Analyzer and key hemostasis test reagents, enhancing diagnostic capabilities for bleeding and clotting disorders.
Takeaways:
- The CN-6000 supports five critical hemostasis tests with FDA-cleared reagents, including PT/INR, APTT, fibrinogen, antithrombin, and D-dimer.
- The analyzer delivers high-throughput, fully automated testing in a compact, expandable design tailored for diverse lab needs.
- Sysmex plans to pursue further market authorizations for the CN-3000 model and additional reagent applications.
Sysmex America, Inc., a 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,” says 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.
Featured Image: Sysmex America has received FDA clearance for its CN-6000 Automated Blood Coagulation Analyzer. Image: Sysmex.
