MedMira Receives CE Mark for MiraCare Rapid HIV Test
MedMira Inc. announced that its MiraCare(TM) Rapid HIV Antibody Test (MiraCare(TM)) has received CE Mark and is now approved for sale throughout the European Union (EU). This regulatory milestone clears the way for MedMira to market and sell MiraCare(TM) in the 25 EU member countries, a market which, up until now, had limited choice in quality rapid HIV tests.
MedMira's rapid HIV test platform stands alone as the only test to receive regulatory approvals in four top tier international forums; Canada, the United States, China and the European Union.
"We are very pleased to receive the CE Mark, the final step in the pre-market process. MedMira is now fully enabled to move forward with fulfillment of our first order for 400,000 MiraCare(TM) tests destined for Spain and capitalize on further sales opportunities in other regions of the EU," said Stephen Sham, chairman and CEO of MedMira. "Once again, we have proven our abilities to navigate regulatory processes globally, and this milestone is further testament to the high quality and accuracy of our rapid tests."
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