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news.Biomerica, a medical technology company, has received CE Mark approval for its five-minute home diagnostic test for detecting microalbumin, micro amounts of albumin in urine.
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With the CE-Marking, Biomerica said that its new one-step test can now be marketed directly to consumers through pharmacies in the EU.
Biomerica’s home test, which will be marketed under the trade name ‘Fortel urine albumin test’, is a five-minute test that individuals can perform in the privacy of their own home. The test utilizes an advanced technology that requires only a sample of urine, the company said.
Zackary Irani, CEO of Biomerica, said: “We are already in discussions with several significant distributors in Europe. This regulatory approval allows us to now sell our new test to consumers throughout Europe.”