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KaibiLi COVID-19 Antigen get PEI approval

KaibiLi COVID-19 Antigen get PEI approval.

The BfArM provides a list according to § 1 sentence 1 TestV of the antigen tests for the direct detection of pathogens of the coronavirus SARS-CoV-2, which are intended by the manufacturer for professional use (“rapid tests ”) and, as far as the BfArM is aware a CE mark wear.

changes to existing listings or new applications for inclusion in the market overview can only be requested by the manufacturer of the test, his European representative or an authorized representative in writing by the manufacturer.

Further information on the list provided by the BfArM as well as on the special approval by the BfArM, inclusion in the list and, if necessary, deletion from the list, the underlying procedures and criteria can be found on website on antigen tests for SARS-CoV-2 .

A market overview according to § 1 sentence 1 TestV on antigen tests for direct pathogen detection of the coronavirus SARS-CoV-2, which are intended by the manufacturer for self-use (“self-tests”) can be found under this link .

All data as submitted by the manufacturer; only the information in the respective instructions for use is binding.

The indication “Evaluation PEI” represents the corresponding overview published on the website of the Paul Ehrlich Institute (PEI) for the comparative evaluation of the sensitivity of SARS-CoV-2 rapid antigen tests ( see PEI website ).

  • “Yes” means that the test has already been evaluated by the PEI with a positive result.
  • “No” means that no corresponding test results are available yet.

Remark: In the event of a negative evaluation by the PEI, the BfArM will delete the corresponding CE-marked test from its list. A positive evaluation of the PEI is a mandatory prerequisite for special approval.

axz


Post time: Aug-31-2021