VivaChek Achieves 510(k) Clearance for BioSieve™ Fentanyl FIA Test Kit and BioSieve™ Toxismart FIA Reader

We are excited to announce that VivaChek has achieved a significant milestone with the US FDA 510(k) clearance of our BioSieve™ Fentanyl FIA Test Kit and BioSieve™ Toxismart FIA Reader. This groundbreaking approval marks the first of its kind in the United States, setting a new standard in fentanyl detection technology.

Our BioSieve™ products leverage advanced Fluorescence Immuno Assay (FIA) technology, offering unparalleled sensitivity in fentanyl detection with a threshold of just 1 ng/mL. Designed for portability and ease of use, the BioSieve™ Toxismart FIA Reader features a handheld Bluetooth reader, rechargeable lithium battery, and provides fast results within 5 minutes. Weighing only 0.36 lbs, this compact device also supports custom configurations to meet diverse testing needs.

This approval is a testament to VivaChek's commitment to innovation and excellence in medical technology. We are proud to lead the way in portable, precise fentanyl detection, enhancing safety and accuracy in drug testing. For more information, please contact Ashish Parikh at and Paul Johnson at