![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 » Novacyt Earns CE Mark for COVID-19 Variant Test
Novacyt Earns CE Mark for COVID-19 Variant Test
![CE mark](https://www.fdanews.com/ext/resources/images/ce-mark.gif?t=1627682539&width=430)
Novacyt has received CE mark certification for SNPsig VariPLEX, a polymerase chain reaction (PCR) test for four SARS-CoV-2 mutations.
Novacyt’s test can detect the UK, South Africa, Brazil and California viral variants, mutations that have spread across the globe.
The point-of-care assay panel returns results in under two hours. It is run on either the company’s q32 systems or open platform instruments that are able to detect the variants using at least four fluorescent channels.
Upcoming Events
-
21Oct