Integrated healthcare company Empower Clinics has secured Medical Device Establishment Licence (MDEL) status for the sale of its KAI Saliva COVID-19 PCR test kits in Canada.
The Food and Drug Administration (FDA) emergency use authorisation (EUA)-approved KAI Medical COVID-19 Saliva Test kit also has CE Mark. The saliva specimen collection device is approved by Health Canada.
Foreign and domestic travellers can use the kit to obtain an RT-PCR test and the test result before arriving or coming back to Canada or going to other countries with similar executive travel restrictions.
Major airlines, cruise lines, and the tourism sector that use Empower’s KAI Saliva will be able to provide solutions for travellers by including the kit purchase part of the ticketing purchase, check-in process, in a kiosk, or on an e-commerce website.
Empower Clinics chairman and CEO Steven McAuley said: “We all have an urgent requirement for a home-based, self-administered Covid-19 saliva test kit that can help open up the economy and facilitate travel that meets the requirements of the executive travel orders.
“We also must utilise our resources, our reach, our capability, do everything we can to assist, be humanitarians, use our voice, strive to provide improved healthcare, and lead the path of progressive healthcare.”
Empower filed MDEL application to import, distribute, and sell KAI Saliva, and has also partnered with MediPro Canada to accelerate the process and use the latter’s approved MDEL status.
MediPro Canada partner Sheila Copps said: “Leveraging the vast network of MediPro Canada with the integrated healthcare capabilities of Empower Clinics and their novel Covid-19 testing products makes for an ideal partnership.”
MediPro provides healthcare products for governments, large corporations, and medical facilities worldwide.