Eurofins Clinical Enterprise has been granted Emergency Use Authorization (EUA) by the US Food and Drug Administration (FDA) for an updated version of its direct-to-consumer (DTC) empowerDX home Covid-19 collection kit. Eurofins’ Covid-19 home nasal PCR kit is directly available to US customers, without prescription, both online and at drug stores in the US.
Fluidigm Corporation has been granted EUA by the FDA for the Azova Covid-19 test collection kit, for use with the Fluidigm Advanta Dx SARS-CoV-2 RT-PCR assay on the company’s Biomark HD platform. The kit is authorised for at-home self-collection through prescription only, for individuals suspected to be suffering with Covid-19 symptoms.
Mobidiag has been granted CE-IVD marking for its Amplidiag RESP-4 molecular diagnostic test for the rapid and combined detection of prevalent respiratory viruses such as SARS-CoV-2 virus, Influenza A, Influenza B and respiratory syncytial virus (RSV).