In vitro diagnostic assay for pancreatic elastase measurement. Used for assessment of pancreatic function and diagnosis of pancreatic insufficiency.
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United States
BUHLMANN Diagnostic Corp (BDC) offers the broadest fecal calprotectin (fCAL) product range in the industry, available in the United States, including FDA cleared and Research Use Only (RUO) kits. These fCAL related tests include FDA 510(k) cleared BÜHLMANN fCAL® ELISA, BÜHLMANN fCAL® turbo & CALEX® Cap; FDA exempt BÜHLMANN fPELA® turbo (Elastase); Tests available as RUO include: Quantum Blue® fCAL rapid tests & Quantum Blue® Infliximab & Adalimumab TDM and Antibody rapid test.
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Gentian USA Inc
United States · 3 relevant products
CerTest Biotec S.L.
Spain · 2 relevant products
Seramun Diagnostica GmbH
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Gentian USA Inc · United States
A particle enhanced turbidimetric immunoassay (PETIA) test for quantitative determination of pancreatic elastase in human fecal extracts, designed to run on clinical chemistry analyzers. The test is developed to run directly with stool extracts from the CALEX® Cap extraction device. Fecal pancreatic elastase is a well-established biomarker to detect exocrine pancreatic insufficiency in patients with conditions such as chronic pancreatitis and cystic fibrosis.
Gentian USA Inc · United States
An immunoturbidimetric method for quantification of calprotectin in fecal samples. The method provides flexibility and when combined with automation and short analysis time becomes an ideal solution for clinical laboratories with varying sample volumes. It can be set up on all automated chemistry analyzers with a measurement range of 20-8000 µg/g calprotectin. When combined with the BÜHLMANN CALEX® Cap extraction device with pre-filled extraction tubes, sample extraction is simplified and performed more hygienically.
CerTest Biotec S.L. · Spain
Pancreatic Elastase is an in vitro diagnostic test for measuring elastase levels in stool samples to assess pancreatic function and diagnose pancreatic insufficiency. The test employs immunoassay methodology for reliable detection of this pancreatic enzyme marker in clinical diagnostics.
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