![FDA, FTC and DOJ Enforcement of Medical Device Regulations FDA, FTC and DOJ Enforcement of Medical Device Regulations](https://www.fdanews.com/ext/resources/Book-Covers-2/BFFDEMDR-COVER.png?height=200&t=1685733565&width=200)
Home » Altona’s COVID-19 Test Grabs CE Mark
Altona’s COVID-19 Test Grabs CE Mark
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.
Upcoming Events
-
11Jul
-
18Jul
-
21Oct