www.fdanews.com/articles/199986-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.