Agilent Releases IVDR-Compliant Instruments, Kits, and Reagents for Use in the European Union
01 Junho 2022 - 9:00AM
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, in compliance with the
new EU IVDR regulation.
This launch of IVDR-compliant Class A products ensures that labs
in the EU who rely on Agilent IVDR instruments, kits, and reagents
in their diagnostic workflows will continue to be able to use these
products without disruption.
The In Vitro Diagnostic Regulation (IVDR) (EU) 2017/746 is a
new, harmonized regulatory framework established to ensure the
present and future safety and performance of in vitro diagnostic
(IVD) medical devices in the European Union market. The IVDR
regulation replaces the previous IVDD directive, under which many
Agilent products have been CE-IVD marked, indicating IVDD
compliance. The launch represents a significant milestone for the
Agilent organization, which faced substantial hurdles due to the
COVID pandemic and related supply-chain challenges.
“Agilent shares the European Commission's vision of enhanced
patient safety and transparency,” said Jenipher Dalton, senior vice
president of Global Quality and Regulatory Affairs at Agilent. “We
remain committed to providing high-quality solutions for delivering
the testing results that physicians and patients in the EU rely on.
Our multi-disciplinary team really came together to make this a
seamless transition, and this result is a testament to their
dedication and professionalism.”
Agilent Class A IVDR-compliant products span the entire Agilent
product portfolio, from qPCR and NGS preparation instruments to
H&E stains, staining instruments, and conjugated secondary
antibody reagents.
About Agilent Technologies
Agilent Technologies Inc. (NYSE: A) is a global leader in the
life sciences, diagnostics, and applied chemical markets,
delivering insight and innovation that advance the quality of life.
Agilent’s full range of solutions includes instruments, software,
services, and expertise that provide trusted answers to our
customers' most challenging questions. The company generated
revenue of $6.32 billion in fiscal 2021 and employs 17,000 people
worldwide. Information about Agilent is available at
www.agilent.com. To receive the latest Agilent news, please
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version on businesswire.com: https://www.businesswire.com/news/home/20220601005431/en/
Naomi Goumillout Agilent Technologies +1.781.266.2819
naomi.goumillout@agilent.com
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