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Beckman Coulter Life Sciences is helping laboratories to prepare for critical upgrades to comply with the new In Vitro Diagnostic Medical Devices Regulation (IVDR) by offering more than 270 reagents for flow cytometry that are IVDR compliant and available immediately. IVDR-compliant single-color antibodies from Beckman are platform-independent and intended to be used in conjunction with other antibodies for multicolor panel design. Conjugated IVDR-compliant antibodies can be used for dia ....
STOCKHOLM, March 1, 2023 /PRNewswire/ Devyser, the pioneering leader in diagnostic solutions, launches today its first IVDR-certified product. Devyser Compact is a rapid genetic test for ....
Certification of QuantiFERON-TB Gold Plus under more stringent EU regulation, classified under Class C Certification marks milestone in QIAGEN's transition to full compliance with new EU regulations ....
CHICAGO, Oct. 20, 2022 /PRNewswire/ Celegence, a global provider of regulatory affairs services for the life sciences industry, is pleased to announce that Navignostics, a global developer ....
Citing a desire for improved patient safety and significant technological advances in recent years, the European Commission (EC) replaced the In Vitro Diagnostic Directive (IVDD) with a new, harmonized regulatory framework: the In Vitro Diagnostic Regulation (IVDR) (EU) 2017/746. Here, Agilent shows how it aims to support you and your clinical lab through this regulatory transition. ....