Chinese RainSureBio is the Third RT-PCR Provider Granted with EUA by FDA
RainSure Biotech’s FastPlex Triplex SARS-CoV-2 detection kit (RT-Digital PCR) was granted Emergency Use Authorization by the US FADA, as announced on June 25.
The kit works with RainSure’s DropX–2000 Series PCR system – a fully enclosed and highly automated system for PCR (Polymerase chain reaction) examination.
So far, the FDA has only authorized emergency use for three digital PCR kit providers dedicated to COVDI-19 viruses. The other two are US well-known companies.
During the breakout, RainSure’s COVID-19 related products were applied in the Wuhan Huoshenshan (literally ‘Fire God Mountain’) Hospital and China’s National Institute of Metrology.