Approval of the HSC on our products for the updating of EU common list : Category A
As a manufacturer of BIOCREDIT COVID-19 Ag – Nasopharyngeal or Nasal, Rapigen Inc. hereby declares that:
The Health Security Committee agreed on the EU common list of both BIOCREDIT COVID-19 Ag Nasopharyngeal and Nasal swab types under “Category A” as following:
※ Category A: Antigen tests for which their performance has been evaluated through prospective clinical field studies and that meet the criteria agreed on 21 September 2021 (see section 2.2) have been placed under the “A-category” of the EU common list. Category A.1 sets out the eligible COVID-19 rapid antigen tests and Category A.2 sets out the eligible COVID-19 laboratory-based antigenic assays.
EU Members are strongly encouraged to use, in particular, the antigen tests included under “Category A” of the EU Common list for the insurance of EU Digital COVID certificate.