Regulatory News & FDA Approvals
The latest regulatory news and FDA approvals.
Euformatics Gains CE-IVD Mark for OmnomicsNGS
Euformatics has updated the marking on its variant interpretation and reporting software as the firm prepares for the EU's new IVDR scheme.
Abionic Obtains CE Mark for One-Minute SARS-CoV-2 Antigen Test
The company is also developing a serology test to provide results in five minutes and quantify IgG levels of the SARS-CoV-2 nucleoprotein and spike protein.
Qiagen Obtains CE Mark for Assay Measuring T-Cell Response to SARS-CoV-2
Qiagen said its IGRA T-cell test can contribute insights into the immune response to a SARS-CoV-2 infection that go beyond what serology testing alone can provide.
Audere Gets FDA Emergency Use Authorization for SARS-CoV-2 At-Home Sample Collection Kit
The kit, developed by digital health firm Audere, is designed for the collection of anterior nasal swab specimens for molecular COVID-19 testing in children and adults.
Eurofins Technologies Obtains CE Marks for SARS-CoV-2, Flu, RSV RT-PCR Kits
The firm has launched the two molecular diagnostic kits to detect and differentiate between the three respiratory infections in the same PCR run.