ABLDx has submitted an EUA application to the FDA for clinical use of the UltraGene® Combo2Screen SARS-CoV-2 Assay as a test for COVID-19.
Frequently Asked Questions (FAQ)
COVID-19 Diagnostic Test Guidance Document
FDA’s Novel Coronavirus (COVID-19) webpage
College of American Pathologists Guidance for COVID-19 Testing
FDA Emergency Use Authorization
COVID-19 Resources and News from the ASCM
John’s Hopkins Coronavirus Resources Center
Click here to download the product sheet, including performance.