Certification for two in-vitro diagnostic (IVD) products - the CupiKIT HIV 1&2 Antibody Test Kit and the CupiKIT Hepatitis B Surface Antigen (HBsAg) Test Kit.
The "A Regulatory Update on the Medical Device and In-Vitro Diagnostic Regulations in the EU (European Union) and UK Training Course (Apr 29, 2026)" training has been added to ResearchAndMarkets.com's ...
CE-marked under the EU IVDR regulation, Diagnostics.AI's platform is the first to deliver AI algorithmic transparency and per-test auditability for clinical PCR diagnostics As the May 26th CE-IVDR ...
DUBLIN--(BUSINESS WIRE)--The "The Role of the Person Responsible for Regulatory Compliance (PRRC) Under the MDR (Medical Device Regulation) and IVDR (In-Vitro Diagnostic Regulation) Training Course" ...
ROCKVILLE, Md. – Feb. 20, 2024 – The Association for Molecular Pathology (AMP), the premier global, molecular diagnostic professional society, today released the results of its Impacts of the European ...
The European Commission (EC) has proposed another delay in the compliance deadlines for the In Vitro Diagnostic Regulation (IVDR) that eases the existing timelines by roughly two and a half years. The ...
MINNEAPOLIS, March 22, 2024 /PRNewswire/ -- Bio-Techne Corporation (NASDAQ: TECH) today announced that Asuragen, part of Bio-Techne's Molecular Diagnostics Division, has completed the Class C ...
The EU's IVDR provides a regulatory basis for establishing the safety and effectiveness of new in-vitro diagnostic (IVD) ...
Yourgene Health (part of the Novacyt group of companies), a leading international molecular diagnostics group, announces that it has received accreditation under the new EU requirements of the in ...
Seegene certifies diagnostic assays for digestive, respiratory, women's diseases, and human papillomavirus to meet IVDR requirements New regulation sets improved standards to ensure higher level of ...
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 ...
DUBLIN--(BUSINESS WIRE)--The "The Role of the Person Responsible for Regulatory Compliance (PRRC) Under the MDR (Medical Device Regulation) and IVDR (In-Vitro Diagnostic Regulation) Training Course" ...
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