![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 » Biocartis’ COVID-19 RNA Diagnostic Gets CE Mark
Biocartis’ COVID-19 RNA Diagnostic Gets CE Mark
November 12, 2020
Biocartis has earned CE mark certification for its Idylla SARS-CoV-2 reverse transcription polymerase chain reaction (RT-PCR) test.
The fully automated RT-PCR test provides qualitative detection of coronavirus RNA from nasopharyngeal swabs that use the company’s rapid molecular diagnostics system, Idylla.
The test provides results in 90 minutes, using a single cartridge, and takes less than two minutes of hands-on time, the company said.
Upcoming Events
-
21Oct