Beckman Coulter Diagnostics has obtained a European CE mark for the use of its laboratory test designed to distinguish between bacterial and viral infections within 20 minutes.

The Danaher company’s regulatory approval, granted under the European Union’s (EU) in vitro diagnostics regulation (IVDR), validates MeMed’s Access MeMed BV (MMBV) test for use with Beckman’s DxI 9000 and Access 2 immunoassay analysers.

The EU designation is the latest development in a partnership between Beckman and MeMed, the test’s original developer, which was expanded in May 2024 for Beckman to become the authorised distributor of Access MeMed in the US and Europe. MMBV received US Food and Drug Administration (FDA) approval in 2021.