Joinstar’s COVID-19 Antigen Rapid Test (Colloidal Gold) anterior nasal-self testing device, was awarded the CE certificate issued by EU.

Illumina said on Tuesday that it has received CE-IVD marking for its TruSight Oncology Comprehensive (EU) assay this month.

The European Union's in vitro diagnostic expert panel has published its first opinion on an In Vitro Diagnostic Medical Devices Regulation (IVDR) submission, delivering a glowing opinion of the filing for a test to screen plasma donor samples for hepatitis E virus (HEV).

Meridian Bioscience announced on Wednesday that its Revogene SARS-CoV-2 test has received Emergency Use Authorization from the US Food and Drug Administration.

The European Union is proposing to delay the go-live date for the incoming medical device regulation pertaining to In Vitro Diagnostics for products that still need assessment of a notified body.

Laboratory Corporation of America said on Friday that it has received Emergency Use Authorization from the US Food and Drug Administration for a combined home collection kit for molecular testing for COVID-19 and influenza A/B.

ANP Technologies announced on Monday that its SARS-CoV-2 rapid antigen test has received Emergency Use Authorization from the US Food and Drug Administration.

On September 23, FDA sent a letter to all manufacturers that received EUA authorization for COVID-19 tests, urgently notifies all these manufacturers of three new requirements for their EUA-authorized tests.

The agency is requiring test developers to monitor emerging mutations and their potential impact on the performance of authorized SARS-CoV-2 tests.

Cepheid announced on Tuesday that it has received Emergency Use Authorization from the US Food and Drug Administration for a new version of its multiplex SARS-CoV-2, influenza, and respiratory syncytial virus test.