Revvity secures FDA clearance for total testosterone immunoassay
The assay enables ChLIA measurement of testosterone markers, delivering diagnostic capabilities for suspected male hypogonadism.
14 May 2026
14 May 2026
The assay enables ChLIA measurement of testosterone markers, delivering diagnostic capabilities for suspected male hypogonadism.
The trial builds on findings from the FLIP-1 Phase I study, which was conducted at the March of Dimes PRC.
The approval covers all 27 EU member states, Liechtenstein, Norway, and Iceland.
The CE mark was granted based on data from retrospective studies in real-world early cognitive decline population.
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