The study was designed to provide clinical evidence of the performance and safety of its Xprecia Prime product. The application comes after wrapping up its study involving 360 patients, which was conducted over four sites across the US in January this year. Xprecia Prime is UBI’s next-generation portable coagulation testing device, designed for fast and reliable testing of blood clotting. Universal Biosensors (UBI) has submitted a 510K application to the US Food and Drug Administration (FDA) for approval to sell Xprecia Prime in the US.
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