Aproval30 Sep 2021 09:57
Submission is already under review different if review not yet commenced.
“ The AIM-traded firm said the submission process had been running in parallel with the useability study conducted by Ulster University since mid-July, with the conclusion of the Ulster study being the final step in the process.
It said the test was already CE-marked for professional-use, and once approved, would allow it to be sold in Europe for home-use as well.
As the global market for antigen testing develops, the company said it believed self-test approval would be a “key” requirement, as had already been seen in the UK.
The submission was already under review by the notified body, the board said.”