Device Dossier
Severe acute respiratory syndrome-associated coronavirus IVDs
Device Dossier for Severe acute respiratory syndrome-associated coronavirus IVDs (CT772 - Severe acute respiratory syndrome-associated coronavirus IVDs,…
Intended purpose
Viral detection of SARS-CoV-2 Virus using rapid PCR method The test could be used as replacement for all existing lab PCR tests. It has the added advantage of no RNA extraction step (thus no lab work required) using only a saliva/swab sample which also makes it suitable for POC testing at scale and mass testing applications such as Border Force, Events, Workplace etc. and has been validated on Biorad and Mygo Pro devices.