Stronger Together: FastQ® RHD fetal plus receives IVDR Certification!
We are thrilled to share an important milestone: BAG Diagnostics has received Class D certification under the EU In Vitro Diagnostic Regulation (IVDR) Annex IX, Chapter II for FastQ® RHD fetal plus. This certification, issued by TÜV SÜD Product Service GmbH, is a testament to our high-quality standards and commitment to regulatory excellence in molecular diagnostics.
A Team Effort Worth Celebrating
Achieving this certification was no small feat. It required immense dedication, collaboration, and expertise from our entire team. A heartfelt THANK YOU to everyone who contributed to this success! This milestone reinforces our mission to provide high-quality, reliable, and innovative solutions in the field of molecular diagnostics. We are excited about what the future holds and remain committed to driving advancements in precision medicine.
About FastQ® RHD fetal plus
FastQ® RHD fetal plus is designed for the non-invasive detection of fetal Rhesus D status using cell-free fetal DNA (cffDNA) from maternal blood plasma. This test is crucial in preventing unnecessary anti-D prophylaxis in Rhesus D-negative pregnant women, ultimately improving patient care and clinical decision-making.