Tags : DE Novo Authorization

Baxter’s Theranova Dialyzers Receives the US FDA’s De Novo Authorization

Shots: The US FDA has granted De Novo authorization to Theranova that delivers expanded hemodialysis (HDx) therapy by filtering the wider range of molecules from the blood, targeting the effective removal of conventional (500-25 kDa) and large middle molecules (25-45 kDa) The Theranova cartridge is designed to be used with existing dialysis machines and offers […]Read More

Vela Diagnostics’ Sentosa SQ HIV-1 Genotyping Assay Receives the US

Shots: The novel HIV-1 Genotyping assay uses the plasma of patients infected with HIV-1 to detect HIV-1 Group M DRMs in the protease, reverse transcriptase, and integrase regions of the pol gene, in a single test Sentosa SQ HIV-1 Genotyping Assay is programmed on Sentosa NGS workflow enabling RNA extraction, PCR setup, library construction, template […]Read More