www.fdanews.com/articles/196927-altonas-covid-19-test-grabs-ce-mark
Altona’s COVID-19 Test Grabs CE Mark
May 4, 2020
Altona Diagnostics’ RealStar SARS-CoV-2 real-time PCR kit has earned the CE mark.
The test detects coronavirus-specific RNA in upper respiratory samples and it can run on a variety of real-time PCR instruments.
The test is for research use and cannot be used in diagnostic procedures. It received an Emergency Use Authorization from the FDA on April 23.