Agilent Receives European IVDR Class C Certification for GenetiSure Dx Postnatal Assay
Agilent Technologies, Inc. (A)
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Source: Business Wire
SANTA CLARA, Calif.--(BUSINESS WIRE)--Agilent Technologies Inc. (NYSE: A) today announced that its GenetiSure Dx Postnatal Assay has received European IVDR Class C Certification. This certification demonstrates that the assay meets the higher standards established by IVDR. It ensures the continued availability of this trusted qualitative assay to clinical geneticists and other healthcare professionals throughout the EU.In vitro diagnostic devices, which include pregnancy tests, COVID-19 tests, urine test strips, and more, are estimated to play a part in 70% of all diagnostic decisions.1 The EU has introduced the IVDR regulatory framework to ensure the safety and performance of these devices. Under the new rules, in vitro diagnostic devices are subject to more stringent regulatory scrutiny to ensure rigorous standards of clinical evidence are met, with greater transparency and tighter standardization.The GenetiSure Dx Postnatal Assay uses Agilent's proprietary array Comparative Gen
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