The test kit is marketed as IVD device by meeting requirements of European In Vitro Diagnostic Directive, is available in over 30 countries worldwide
PerkinElmer recently announced that the US Food and Drug Administration (FDA) has provided Emergency Use Authorisation (EUA) for the Company’s new Coronavirus RT-PCR test. Clinical laboratories certified under Clinical Laboratory Improvement Amendments (CLIA) can immediately begin using this kit to detect SARS-CoV-2, the virus that causes COVID-19. PerkinElmer’s RT-PCR test is marketed as an in vitro diagnostic (IVD) device by meeting the requirements of the European In Vitro Diagnostic Directive (IVDD) and is available in over 30 countries worldwide.
“Despite the challenging environment, our employees have demonstrated unwavering commitment over the past two months to combat this global pandemic,” said Prahlad Singh, President and CEO, PerkinElmer. “The breadth of PerkinElmer’s total workflow solution puts us in a unique position to rapidly address the needs of our clinical diagnostics customers.”