June 25, 2025 – Sysmex America 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
Laboratories with high workloads may opt for the optional sampler that provides an expandable sample loading capacity. According to the press release, Sysmex will continue efforts to obtain market authorization for the Automated Blood Coagulation Analyzer CN-3000 and additional reagent applications.