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BIOPHEN™ Heparin LRT: IVDR certification successfully completed

Measuring all Xa inhibitors currently available on the market

We are pleased to announce that for our proven assay BIOPHEN™ Heparin LRT  the certification according to the requirements of EU regulation 2017/746 on in vitro diagnostic medical devides (IVDR) has been successfully completed.   

The kit's features and advantages at a glance: 

  • Measurement of all Xa inhibitors currently available on the market (including DOACs, danaparoid, fondaparinux)
  • No interference from PF4 thanks to dextran sulfate added in the factor Xa reagent* 
  • Measurement of DOACs without interference from heparins
  • Validated applications for all common analyzers
  • Ready to use liquid reagents with excellent stability: 6 months at 2-8°C, up to 3 months on board (depending on analyzer used)  

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*Amiral, J.; Amiral, C.; Dunois, C. Optimization of Heparin Monitoring with Anti-FXa Assays and the Impact of Dextran Sulfate for Measuring All Drug Activity. Biomedicines 2021, 9, 700.