FDA Watch: OraSure’s Collection Device for Cobas STI Testing Receives Approval
At-home sample collections can be mailed to a clinical laboratory
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FDA Watch: Zepto Life Technology Receives FDA Breakthrough Designation for Blood-Based Mold Test
Its FungiFlex assay can make determining the cause of fungal infections vastly more accurate
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New Enhancing CLIA Act: What Lab Directors Need to Know
The proposal seeks to move any future LDT authority away from the FDA
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FDA Lists 27 Current COVID-19 Tests that May Not Detect Omicron
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HHS Reinstates FDA Premarket Review of LDTs
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FDA Expands Recall of Ellume COVID-19 Home Test Kits
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FDA Targets High Throughput COVID-19 Tests for Recall Due to Risks of False Positives
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FDA Hikes Premarket Application User Fees by 2.5 Percent
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FDA Hikes Premarket Application User Fees by 2.5 Percent
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FDA Clears the Way for Over-the-Counter Sale of COVID-19 Home Test Kits
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FDA Sounds Alarm on Potential Impact of Genetic Mutation on SARS-CoV-2 Molecular Test Accuracy
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FDA Clears the Way for Over-the-Counter Sale of COVID-19 Home Test Kits
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