Test4D Serum is a qualitative test to detect Vitamin D levels in the blood.
NanoSpeed Diagnostics Inc. is pleased to announce that Health Canada has approved Test4D Serum which is indicated to be used to detect Vitamin D in blood serum. Test4D Serum is one of the many products in the Company’s catalogue that uses NanoSpeed’s proprietary technology to detect Vitamin D deficiency in the blood, both quantitatively and qualitatively. Test4D was developed as the world’s first point-of-care test for Vitamin D deficiency and launched in 2013. ISO 13485 MDSAP certification in 2024 for the NanoSpeed manufacturing facility based in Edmonton, Alberta was critical for the approval from Health Canada.
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“We are so pleased to achieve this significant milestone in Canada” said Dr. Seema Gupta, CEO of NanoSpeed. “As a company based in Alberta that has sold millions of our test globally, we are so happy to finally obtain approval to sell our test at home to patients and healthcare practitioners who increasingly recognize the importance that Vitamin D sufficiency plays in our everyday health.”
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Dr. Seema Gupta continues, “As we celebrate this milestone, we want to thank our customers, distribution partners, employees, research and development collaborators, investors and government funders, both federally and provincially, for their continued support.”
This regulatory approval for Test4D follows the 2014 CE Mark approval by the European Union (EU). NanoSpeed’s other commercial point of care products for Vitamin B12, Ferritin, and Vitamin A have already received approvals to use CE Mark and UKCA.
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Source – businesswire
