Exception for antigenic tests for COVID-19 self-testing

On February 24, 2021, the company Dialab spol. s r.o. obtained the exception of placing a medical device on the market in the Czech Republic. This exemption concerns two medical devices that can be used for self-testing on COVID-19 and their use is in the interest of public health protection. The application submitted to the Ministry of Health of the Czech Republic was prepared by MeDeCorp s.r.o., which provides Dialab spol. s r.o. medical device management.

The exception applies to the following two medical devices:

  • Flowflex SARS-CoV-2 Antigen rapid test
  • Insert DIAQUCIK COVID-19 Ag Cassette

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