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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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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The tests for risk assessment and management of sepsis and iron deficiency will be available for sale throughout the European Union.
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A new initiative seeks to provide recommendations for optimizing diagnostic solutions to combat antimicrobial resistance.
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The device is the first of the company’s Alinity family of diagnostic instruments to launch.
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