FDA Grants First De Novo Authorization for COVID-19 Home Use Test
Cue Health has received De Novo authorization from the FDA for its Cue COVID-19 Molecular Test, designed for both home and point-of-care use.
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Search Results for: covid-19
Why Better Sepsis Diagnosis Results in Better Outcomes
Delay in sepsis diagnosis increases the risk of dying by 8% every hour; and can lead to the unnecessary use of strong antibiotic therapies.
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Avacta Acquires Coris Bioconcept
With the acquisition, Avacta gains Coris’ product portfolio including diagnostic tests for respiratory, gastro-enteric, and blood-borne pathogens and for the detection of antibiotic resistance markers.
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FDA Issues Class I Recall for COVID-19 At-Home Tests
This Class I recall is for certain COVID-19 at-home test kits containing liquid solution that may be contaminated with bacteria.
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Program Supports Need to Expand Diagnostic Testing Access
The CDC’s OneLab TEST is designed for anyone who performs or coordinates diagnostic testing at non-laboratory sites.
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