HomeLatest NewsFederal NewsFDA Approves Combo Test for Flu, COVID-19; Alerts Providers to Medical Device...

FDA Approves Combo Test for Flu, COVID-19; Alerts Providers to Medical Device Risks

On Thursday, the FDA issued an EUA for SEKISUI Diagnostics, LLC’s OSOM Flu SARS-CoV-2 Combo Home Test, a single use test intended to detect and differentiate influenza A and B (commonly known as flu) and SARS-CoV-2 (the virus that causes COVID-19), in individuals with signs and symptoms of respiratory infection consistent with COVID-19 within the first four days of symptom onset when tested at least twice over three days with at least 48 hours between tests. The test is authorized for people aged 14 years or older with self-collected anterior (nares) nasal swab specimens and those aged two years or older when an adult collects the nasal swab specimens. The OSOM Flu SARS-CoV-2 Combo Home Test is the first over the counter at-home antigen test that detects both flu and COVID-19 viruses to receive an EUA following collaboration with the National Institutes of Health Independent Test Assessment Program.
In other news, the FDA last week recommended health care providers monitor patients with the Hintermann Series H3 Total Ankle Replacement system for potential device failure, and patients with certain implantable BioZorb breast tissue markers for potential serious complications.

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