FDA Clears Alere Immunoassay Analyzer
The diagnostic system features objective results interpretation and connectivity capabilities, and can be used to evaluate lateral-flow immunoassays in a wide variety of formats.
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Search Results for: point-of-care
BD Immunoassay Meets FDA’s New Performance Requirements for RIDTs
FDA has reclassified antigen-based rapid influenza virus antigen detection systems intended to detect influenza virus directly from clinical specimens from Class I devices into Class II devices subject to special controls.
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Abbott Diagnostic Systems Score CE Mark
The clinical chemistry and immunoassay technologies allow for cost-effective volume growth in a footprint half the size of Abbott’s current diagnostics systems.
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Europium Conjugation Kit Designed for High Sensitivity
The new kit facilitates the generation of highly stable europium conjugates, often allowing 10- to 100-fold improved limits of detection compared with other common particles.
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Oral Cancer Tests Capture Biomarkers Using Saline Rinse
The tests are based on technology that accurately measures CD44, a tumor-initiating and stem cell-associated biomarker, and total protein levels.
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