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CE Mark Granted for Hematology Analyzer
Devices Submissions and Approvals
Beckman Coulter Diagnostics received a CE Mark for its DxH 520 hematology analyzer.
The company used its flagship DxH 800 analyzer as the predicate product for the DxH 520. The system uses just two reagents and includes on onboard cleaner.
The analyzer is pending clearance by the FDA and is not yet available for in vitro diagnostic use in the United States.