More than a week after granting EUAs for COVID-19 antibody tests produced by Siemens Healthineers (ETR: SHL), FDA has authorized additional tests from the German medtech giant.
The new EUAs, granted June 8, are for tests running on Siemens Healthineers Dimension Vista and Dimension® EXL systems. The tests already started shipping on May 29.
Siemens Healthineers previously announced EUAs for comparable tests running on Atellica IM immunoassay analyzers and Advia Centaur XP and XPT analyzers.
The company is making the tests in Walpole, Mass. and Newark, Del., and distributing them out of Plainfield, Ind. It’s ramping up production, with a goal of manufacturing capacity exceeding 50 million tests per month across its testing platforms.