Recently, Hotgen Coronavirus (2019-nCoV)-Antigentest has officially passed 3a validation of the UK Department of Health and Social Care (DHSC), which proves that the antigen test not only has high specificity, but also has high detection sensitivity.
Companies that have already registered their devices in the EU will still be able to sell their products in Great Britain until June 2023. From this point, they will be required to register their device for UK Conformity Assessed (UKCA) marking.
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