UPDATE: FDA Clarifies Abbott Alinity Kits’ Recall Is for Software, Details Fix
The FDA has updated the Abbott Alinity Kits’ recall is for a software issue, which can be corrected with an update.
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Search Results for: covid-19
New Sample Transport Reagents Address COVID-19 Testing Lab Risks
Thomas Scientific has partnered with Truckee Applied Genomics (TAG) to distribute its patient sample transport reagents.
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FDA Response to COVID Gives Insights for Regulatory Future of LDTs
Certain temporary deviations in FDA policy in response to the COVID-19 pandemic may offer a blueprint for regulatory oversight of LDTs.
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DRUL Saliva Test Accuracy for COVID-19 May Surpass Swab
Rockefeller University’s “DRUL” saliva test performs as well as, if not better, than FDA-authorized nasal and oral swab tests.
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Cairn Diagnostics Approved for At-Home Admin of Breath Test
Cairn Diagnostics has announced that the U.S. FDA has expanded the approval of the company’s 13C-Spirulina GEBT to now include “at home” administration.
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