FDA Authorizes Symbiotica COVID-19 Self-Collected Antibody Test
The US FDA has issued an EUA for the Symbiotica COVID-19 Self-Collected Antibody Test System, the first antibody test authorized for use with home collected dried blood spot samples.
Category: Testing
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FDA Authorized First Over-the-counter COVID-19 Test – Useful But Not a Game Changer
Soon, people in the U.S. will be able to pick up a rapid antigen test for COVID-19 from their local drugstore without a prescription.
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FDA Okays First Combo FLU + COVID-19 Diagnostic for Home Testing
The FDA authorized Quest Diagnostics RC COVID-19 +Flu RT-PCR Test for home collection of patient samples to detect both COVID-19 and influenza A and B (flu).
FDA Authorizes GWU SARS-CoV-2 Test
The FDA issued an emergency use authorization for the GWU SARS-CoV-2 RT-PCR Test to George Washington University’s Public Health Laboratory.
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Ventilators: Make the Time for Testing and Calibration
Despite innovation and advancements in modern ventilator management, it’s still essential for clinicians to know that the information they provide is accurate.
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Hans Rudolph Develops Testing Kit to Aid COVID-19 Ventilator Demand
Hans Rudolph Inc has developed a Ventilator Testing Kit that incorporates the company’s SmartLab Data Acquisition System and other Hans Rudolph respiratory testing components.
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FDA Authorizes ‘Pooled’ COVID-19 Testing for up to Four Samples
The FDA authorized a Quest Diagnostics COVID-19 test for “pooled” samples, allowing four people to be tested with one assay.
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FDA Clears Nonin’s Handheld CO-Pilot Device for EMS
Nonin Medical’s CO-Pilot is a handheld device with wireless capabilities that helps EMS, firefighters and military personnel measure patient parameters following cardiac arrest, traumatic injury, carbon monoxide or smoke inhalation.
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FDA Authorizes Enzo Biochem’s SARS-CoV-2 Test
Enzo Biochem Inc has received FDA Emergency Use Authorization (EUA) for its Ampiprobe SARS-Cov-2...
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FDA Authorizes BD Veritor 15-min COVID-19 Antigen Test
The US FDA has authorized the BD Veritor Plus SARS-CoV-2 assay, a rapid, point-of-care, antigen test manufactured by Becton Dickinson.
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Products 2020: Blood Gas Analysis
The latest blood gas analyzers on the market from Instrumentation Laboratory, Radiometer America, Nova Biomedical, and Siemens Healthineers.
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Products 2020: Diagnostics & Testing
A look at the latest diagnostic and testing products from Ambu, Rheonix, BioFire, Hologic, and Abbott.
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FDA Revokes Authorization for Chembio Antibody COVID-19 Test
The US FDA revoked the emergency use authorization of the DPP COVID-19 IgM/IgG System, a SARS-CoV-2 antibody test from Chembio Diagnostic System Inc, due to performance concerns with the accuracy of the test.
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FDA Authorizes First Sequencing-based Test for COVID-19
The US FDA issued an emergency use authorization for the Illumina COVIDSeq Test, the first COVID-19 diagnostic test utilizing next generation sequence technology.
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CDC Develops Test to Detect Both COVID-19 and Influenza
The CDC is seeking emergency use authorization for a new diagnostic test that can simultaneously detect the SARS-CoV-2 coronavirus and the influenza virus.
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