2026.07.24
Leadgene Biomedical's Indoxyl Sulfate ELISA Kit Receives IVD Approval in Australia
We are thrilled to share a major milestone for Leadgene! Our independently developed and manufactured in vitro diagnostic (IVD) reagent for kidney function assessment, Leadgene® Indoxyl Sulfate (IS) ELISA, has successfully completed medical device registration with the Australian Therapeutic Goods Administration (TGA) and was officially listed on the Australian Register of Therapeutic Goods (ARTG) on July 21, 2026.