www.fdanews.com/articles/205229-ctk-biotech-gains-ce-mark-for-onsite-covid-19-self-test
CTK Biotech Gains CE Mark for Onsite COVID-19 Self-Test
November 8, 2021
Poway, Calif.-based CTK Biotech has received a CE mark certification for its Onsite COVID-19 antigen self-test.
The single-use test, which can detect SARS-CoV-2 antigens in nasal swab specimens from infected individuals, is intended for use with self-collected samples within the first seven days after symptoms begin.
CTK Biotech said it will begin shipping the test this month to countries that accept the CE mark.