BioSieve™ Fentanyl FIA Home Test Kit and BioSieve™ Toxismart FIA Reader Get FDA Approval for OTC Use

We are proud to announce that VivaChek a leading innovator in diagnostic solutions, has achieved a significant milestone. Our BioSieve™ Fentanyl FIA Home Test Kit and BioSieve™ Toxismart FIA Reader have received FDA approval for over-the-counter (OTC) use, making them the first-ever devices of their kind to reach this milestone.

This FDA approval paves the way for individuals and families to access reliable, at-home testing solutions to detect fentanyl, a substance at the center of a growing public health crisis. By offering a safe, easy-to-use, and highly accurate testing kit, BioSieve™ VivaChek is committed to enhancing personal safety and empowering individuals with the knowledge they need to make well informed decisions.

This marks a breakthrough in public health efforts, as consumers now have access to professional-grade testing technology from the comfort of their own homes, helping them stay safe and informed. With fentanyl contributing to an increasing number of unintentional drug-related overdoses, this FDA approval provides critical support in the fight against this epidemic.

For more information, please visit https://www.vivachek.com/en/prods/biosieve-toxismart-system.htmlContact Ashish Parikh (Ashish.Parikh@vivachekdx.com) or Paul Johnson (Paul.Johnson@vivachekdx.com) for further information.