FDA Grants CLIA Waiver to Rapid Screening Test for Syphilis
FDA’s action will permit the Syphilis Health Check test to be used by untrained healthcare workers in a variety of nontraditional settings.
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FDA Clears Influenza Test Kit for Additional Strains
The Simplexa Flu A/B & RSV Direct kit from Focus Diagnostics, Cypress, Calif, has received FDA clearance for eight additional influenza strains, including H3N2v and the novel avian influenza A strain H7N9.
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January 2015: Product News
Featured products include the Cytation 5 cell imaging multimode readerfrom BioTek, an ebola disinfectant from Mueller Sports Medicine, and a lab coat with multiple pockets for electronic devices from ScotteVest.
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Abbott Launches Iridica Infectious Disease Testing Platform in Europe
Abbott says its latest platform has the potential to change how serious infections are detected and identified, providing doctors with information needed to start treating critically ill patients sooner, and reducing inappropriate use of broad-spectrum antibiotics.
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CLIA-Waived HIV Test Enables Earlier Detection
FDA has granted CLIA-waived status to the Alere Determine HIV-1/2 Ag/Ab Combo test, making it eligible for use in physician offices and clinics. The fourth-generation test enables faster detection, within days of infection.
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