Sysmex America receives FDA clearance for automated blood coagulation analyzer CN-Series CN-6000

June 25, 2025

Sysmex America, Inc. 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.  

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

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