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)
*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. https://doi.org/10.3390/biomedicines9060700
