We are thrilled to announce today that in February 2020 Alveo Technologies was presented with a Food and Drug Branch License (FDB License) after an in-person inspection by a Food and Drug Investigator from the State of California Food and Drug Branch of the Food and Drug Administration. This license is critical to the success of our company as it is a requirement of the State of California in order to manufacture medical devices or drugs intended for human use (whether clinical or commercial), regardless if the product will be used in California, the U.S. or exported.
Our facilities, quality management system and design control practices were reviewed by the state investigator and were found to be in compliance with the California Health and Safety Code requirements. We are thrilled to have been awarded this licensing and approval as it greatly impacts our ability to conduct our business and achieve the goals we have set out for ourselves in redefining the landscape of rapid novel diagnostic testing.
As a California-based, company, this is a significant milestone as the State requires that all firms manufacturing medical devices or drugs in the State of California, including In Vitro Diagnostic manufacturers, must be licensed prior to distributing their manufactured medical devices or drugs.
With the FDB License, we are further empowered to bring our revolutionary products to consumers, health professionals and treatment providers, and rapidly connect them in real-time with fast and accurate results. Our agile and dynamic be.well™ platform is designed to empower people with the information necessary to make informed care decisions by providing rapid diagnosis of and surveillance for Flu A/B, COVID-19, and RSV – which are among the highest causes of mortality and morbidity in the world today. It is a privilege to continue pursuing our vision of intercepting the spread of infectious diseases for Everyone, Anytime, Everywhere™.
To learn more about Alveo Technologies and the work we are doing to change the landscape of diagnostic testing, please visit https://www.alveotechnologies.com/
By Ron Chiarello, PhD, Founder and CEO, Alveo Technologies