A Particle-Enhanced Turbidimetric Immunoassay (PETIA) for in vitro diagnostic testing of cystatin C in human plasma and serum samples. The assay is used for quantitative determination of cystatin C to assess glomerular filtration rate (GFR) and kidney function in patients of all ages. It is FDA 510(...
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United States
Gentian Diagnostics develops high-quality assays for open channel clinical chemistry platforms to increase efficiency and reduce costs in human and veterinary diagnostics. The company targets key areas within kidney disease, infection, inflammations and heart failure. The flagship product, Cystatin C, is FDA 510(k)-cleared since 2008 and CE-marked, offering a precise and reliable solution for estimating GFR, complementing creatinine-based testing. The portfolio includes Cystatin C, plasma/serum calprotectin (CE-marked/US RUO), faecal calprotectin, pancreatic, canine CRP and RBP. The pipeline includes NT-proBNP in the verification phase and other assays under development. Gentian assays are open-channel and run on all major clinical chemistry analyzers with no need for new instruments. Headquartered in Norway, the company is supported by teams in the US, Sweden, and China.
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