FDA Publishes New Website: A Closer Look at Covid-19 Diagnostic Testing
The overview is intended for healthcare providers, test purchasers, and public health staff who want to know more about different types of tests.
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Search Results for: covid-19
FDA Authorizes First Covid-19 Test for Self-Testing at Home
The Lucira Covid-19 All-In-One Test Kit is a molecular (real-time loop mediated amplification reaction) single-use test that is intended to detect the novel coronavirus SARS-CoV-2 that causes covid-19.
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APC Health Authorized for SalivaDirect Noninvasive Covid-19 Test
The SalivaDirect covid-19 test provides analytical sensitivity of 99% and is accurate 94% of the time.
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A Comparative Look at Lab Management Systems
Tools such as laboratory information management systems and electronic laboratory notebooks can not only streamline operations, they can also help meet emergency needs.
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From the Commissioner: FDA’s Ongoing Commitment to Transparency for Covid-19 EUAs
I want to take a moment to reaffirm FDA’s commitment to transparency around the EUA process and share some updates on our plan to provide more information about FDA’s decisions to issue, revise or revoke EUAs for drugs and biological products, including vaccines.
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