Home » LumiraDx Gains CE Mark for COVID-19 Test
LumiraDx Gains CE Mark for COVID-19 Test
London-based LumiraDx has earned CE mark certification for its RNA STAR Complete COVID-19 test.
The assay, for which the FDA granted Emergency Use Authorization in October, is intended to support rapid testing programs in full-scale laboratories and mobile lab units.
The RNA test uses a direct amplification method that combines cell breakdown and amplification in a single step, detecting viral nucleic acid in 20 minutes or less on common polymerase chain reaction systems, the company said.
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