6 COVID-19 test kits obtained CE mark

Cepheid announced on Thursday that it has obtained the CE mark for a rapid molecular test to detect the SARS-CoV-2 virus. The new test will begin shipping this month.

LumiraDx on Thursday announced it has obtained CE marking for its five-minute SARS-CoV-2 Ag Ultra Test.

Achiko announced Tuesday that it has obtained the CE mark for its COVID-19 AptameX test and system, enabling its use in the European Union and other regions that accept the designation.

Qiagen said on Monday that a higher-capacity version of its QiaStat-Dx automated syndromic testing system has received CE marking.

BioMérieux announced on Friday that it has obtained the CE mark for two immunoassays to detect Chikungunya virus infection.

Hologic announced on Tuesday that its Aptima CMV Quant assay for cytomegalovirus has been approved by the US Food and Drug Administration.

On April 13, the SARS-CoV-2 Rapid Antigen Test (immunochromatography Assay) developed by Sansure Biotech Inc. has obtained CE certification! This means that the test can be sold in EU countries and countries that recognize EU CE certification.

SeekIn said on Thursday that it has received CE marking for its LeukoPrint Molecular Karyotyping Kit for the diagnosis and stratification of leukemia patients.

Thermo Fisher Scientific said on Tuesday that it received CE-IVD marking for the Ion Torrent Genexus Dx Integrated Sequencer this month and is making the platform commercially available for diagnostic testing and clinical research.