In-vitro Diagnostic Medical Device Regulation 2017/746 (IVDR) applies from 26 May 2022. We have implemented the new requirements immediately in place from this date and we are also able to announce:
All CE marked products that we currently supply will comply with the new IVDR requirements and their future CE conformity is therefore not in question.
This obviously also applies to our proven kit BIOPHEN™ Heparin LRT (ref. 221011/221013/221015) - its features and benefits at a glance:
- Ready-to-use liquid reagents, no reconstitution errors
- On board stability of up to 12 weeks (depending on analyzer) – applicable 24 hours
- CE marked for all Xa inhibitors currently available on the market
- All three direct Xa inhibitors can be measured using the same calibration curve (valid for ACL TOP, Atellica® COAG 360, BCS® XP, CS-Serie)
- Three different formats available – for low, medium and high sample throughputs
- Excellent calibration stability
- No interference from Heparin (analogues) when measuring direct Xa inhibitors
- Validated applications available for all common analyzers
