COVID/Flu Multiplex Test Receives EUA
Aptitude Medical Systems has received FDA emergency use authorization for its Metrix COVID/Flu multiplex test.
Tag: FDA emergency use authorization
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FDA Issues EUAs for Two OTC COVID-19 Tests
On December 22, 2022, the FDA issued emergency use authorizations (EUAs) for two additional OTC at-home COVID-19 Tests.
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Poll Shows High Interest in At-Home Medical Tests
A new poll shows, 48% of people age 50 to 80 have bought at-home medical tests, including 32% who had bought COVID-19 tests.
Revival Health Medical Supply Awarded Master Distributorship for Boson COVID Test
Revival Health was awarded as the exclusive distributor of Xiamen Boson Biotech’s Rapid SARS-CoV-2 Antigen Tests following a joint agreement.
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Cue Health Makes De Novo Submission to FDA for Clearance of Molecular COVID Test
Cue Health made a submission to the U.S. FDA for full clearance of its molecular COVID-19 test for at-home and point-of-care use.
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Media Pooling Strategy Added to SARS-CoV-2 RT-PCR Test
The ViroKey SARS-CoV-2 RT-PCR Test v2.0 has the additional capability to be used for pooling, using a three-in-one media pooling strategy.
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MicroGEM Granted FDA Emergency Use Authorization for Fast PCR COVID Test
Molecular biology company MicroGEM has been granted Emergency Use Authorization (EUA) by the FDA for its fast, saliva-based COVID PCR Test.
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FDA Authorizes First COVID Diagnostic Test Using Breath Samples
The U.S. FDA issued an emergency use authorization for the first COVID diagnostic test that detects chemical compounds in breath samples.
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Proof Diagnostics Seeks Emergency Use Authorization of CRISPER-Based POC COVID Test
Proof Diagnostics announced the submission of its EUA request for review to the U.S. FDA for its POC molecular diagnostic test for COVID-19.
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Helix COVID Test with ‘Locker’ System Gets Emergency Use Authorization
Helix received FDA Emergency Use Authorization for its SARS-CoV-2 Test and Helix COVID-19 Self-Collection Kit.
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Anavasi Diagnostics’ COVID Test Submitted for FDA EUA Approval
The initial EUA submission requests approval to claim effectiveness of the test for administration by a licensed medical professional.
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FDA Authorizes On/Go One Compact, Rapid Antigen COVID Test
The new antigen test delivers results with 98.2% accuracy in 15 minutes and detects all major known variants, including Omicron, via an easy-to-use test.
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How Cayuga Health System Nimbly Met COVID Testing Demands
The Cayuga Health System Laboratory reduced turnaround times for COVID-19 testing from two weeks to same-day and quickly scaled to meet surges.
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FDA Expands ChromaCode’s HDPCR SARS-CoV-2 Assay Emergency Use Authorization
The FDA has expanded the EUA of ChromaCode’s HDPCR SARS-CoV-2 Assay to include several new qPCR instruments and use of 384-well plates.
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MaximBio’s COVID-19 Antigen Home Test Gets Distribution Agreement
The ClearDetect COVID-19 Antigen Home Test (ClearDetect) which received Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration.
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LumiraDx COVID Antigen Test Detects the Omicron Variant
In-house wet testing with the virus demonstrated that the LumiraDx SARS-CoV-2 Antigen test detects the Omicron variant.
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Carolina Liquid Chemistries’ COVID-19 Antigen Home Test Finds Authorized Distributor
The company will distribute its Flowflex COVID-19 Antigen Home Test kit via a partnership it made with authorized distributor Alltests Clinical Solutions.
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Roche At-Home COVID Test Granted FDA Emergency Use Authorization
The U.S. Food and Drug Administration (FDA) has granted Emergency Use Authorization (EUA) for Roche’s COVID-19 At-Home Test.
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