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 ...
SANTA CLARA, Calif.--(BUSINESS WIRE)-- Agilent Technologies Inc. (NYSE: A) today announced that previously CE-IVD marked instruments, kits, and reagents were released as IVDR Class A on May 26, 2022, ...
Drawing a positive conclusion about the IVDR: Sales Representative Dr. Thorsten Heinlein, CEO Dr. Erdmann Flindt, COO Dr. Carsten Stollfuß, and Laboratory Manager Dr. Jessica Walkowiak. The Aamino a ...
Research assistant Nicole Gebert contributed to this article. In vitro diagnostic medical devices (IVDs), hence devices used for medical tests on samples such as blood or tissue that have been taken ...
Recently, Autobio’s Automated Mass Spectrometry Microbial Identification System, Autof MS Series, has obtained the EU IVDR (In Vitro Diagnostic Regulation) Class C registration certificate from the EU ...
Laura Nea, Vice President of Quality & Regulatory Management at Tecan (Männedorf, Switzerland), discusses the benefits and challenges of transitioning to in vitro diagnostic regulation (IVDR) and ...
Mechelen, Belgium, 02 June 2025 – Biocartis NV (“Biocartis”), an innovative molecular diagnostics company, is pleased to announce that its Idylla™ EGFR Mutation Test has received the European Union ...
SHANGHAI, Oct. 11, 2023 /PRNewswire/ -- Shanghai Kehua Bio-engineering Co., Ltd ("KHB" or "the Company", Stock code: 002022.SZ), China's leading In Vitro Diagnostic (IVD) company has achieved a ...
Today, CellaVision has reached another important milestone and announces that its new CellaVision Bone Marrow Aspirate (BMA) Application has received CE marking approval as a Class C product under the ...
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