Co-Diagnostics Intends to Submit Enhanced Version of COVID-19 Test to FDA for 510(k) Clearance
Co-Diagnostics has withdrawn its 510(k) application for its Co-Dx PCR COVID-19 Test in favor of submitting an enhanced version.
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Search Results for: covid-19
FDA Clears Hologic’s Aptima SARS-CoV-2 Assay
Hologic, Inc. has received FDA 510(k) clearance for its Aptima SARS-CoV-2 assay, initially authorized for emergency use in 2020.
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Multiplex Test for SARS-CoV-2, Flu A, Flu B, and RSV Receives 510(k) Clearance
Thermo Fisher Scientific has received FDA 510(k) clearance for its Applied Biosystems TaqPath COVID-19, Flu A, Flu B, RSV Select Panel, a real-time PCR multiplex test.
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Vitamin C and SARS-C0V-2 Simultaneously Detected with Biosensing Platform
Researchers developed a portable, at-home, wireless device that simultaneously detects SARS-CoV-2 and vitamin C levels.
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Scientists Pinpoint Mutations That Supercharged SARS-CoV-2 Spread
Researchers identified key SARS-CoV-2 mutations that increased the virus’ ability to spread via a novel genomic surveillance model.
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