This test is registered and for practical use in: Germany Bfarm https://antigentest.bfarm.de/ords/f?p=110:100:1379568298725:::::&tz=-7:00 Test ID AT390/21 Italy MOH https://www.salute.gov.it/interrogazioneDispositivi/RicercaDispositiviServlet?action=ACTION_MASCHERA Under CTK Biotech, Inc. Device registration number is 2095755 France ANSM https://covid-19.sante.gouv.fr/tests Denmark authorization: https://laegemiddelstyrelsen.dk/da/udstyr/covid-19-antigen-test-og-ivd/covid-19-antigen-test-til-selvtest/ Practical usage: To date, there are 11211460 tests that are in use or scheduled to be shipped to EU in the countries of Denmark, France, Germany, Italy, Ireland, Romania, Lithuania and the United Kingdom.
View current HSC list
2021-07-07 Added to mutual recognition list
Type of antigen
The database contains publicly available In Vitro Diagnostic Medical Devices for COVID-19 and it is being updated periodically. Please note that additional performance (as retrieved from manufacturers web pages) is provided only for devices commercially available with CE-IVD mark. Acknowledgements