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FDA Offers New Guidance on Validating SARS-CoV-2 Tests in “Non-Laboratory” Settings

FDA Offers New Guidance on Validating SARS-CoV-2 Tests in “Non-Laboratory” Settings

by Glenn S. Demby | Aug 20, 2020 | Articles, Essential, FDA-lir, Laboratory Industry Report, LDTs-lir

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Labs, Universities and Even Computer Companies Target Point-of-Care COVID-19 Test Development

Labs, Universities and Even Computer Companies Target Point-of-Care COVID-19 Test Development

by Glenn S. Demby | Apr 1, 2020 | Deals-lir, Essential, Laboratory Industry Report

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Laboratory Developed Tests: The VALID Act is Back

Laboratory Developed Tests: The VALID Act is Back

by Glenn S. Demby | Mar 18, 2020 | Articles, CLIA-nir, Essential, Laboratory Industry Report, National Lab Reporter, News-nir

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FDA Watch: Agency Finalizes CLIA Waiver Guidance for New IV Devices

FDA Watch: Agency Finalizes CLIA Waiver Guidance for New IV Devices

by Glenn S. Demby | Mar 6, 2020 | Essential, FDA-lir, Industry Buzz-lir, Laboratory Industry Report

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Labs, Universities and Even Computer Companies Target Point-of-Care COVID-19 Test Development

Diagnostic Deals: Urgent Need for Coronavirus Diagnostics Fuels Strategic Collaboration

by Glenn S. Demby | Mar 1, 2020 | Deals-lir, Essential, Laboratory Industry Report

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