The company did receive interim authorization in Canada in August, but the FDA took until November to recommend Lucira re-submit for a point-of-care approval. That would allow the test to be used ...

The Navy granted CSRA an interim authorization to conduct a field test of the commercial off-the-shelf human resource management system in support of the service branch’s manpower, personnel ...

The emergency use of these products is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for ...

Cue Health's first-of-its-kind COVID-19 test was the first FDA-authorized molecular diagnostic test for at-home and over-the-counter use without a prescription and physician supervision.

GenMark’s test was developed for the qualitative detection of SARS-CoV-2 virus in nasopharyngeal swab samples for patients suspected of COVID-19 by their health care provider. Rapid and easy ...

Federal regulators revoked the authorization of a COVID-19 test that has been given to millions of people for free across the country, including hundreds of thousands in Los Angeles. The Food and ...

The Food and Drug Administration issued an emergency authorization for the first over-the-counter, at-home combination flu and Covid test on Friday, just two days after the company that makes the ...

FDA grants authorization of the first at-home test for COVID-19 and the flu. KEYT. By Patricia Martellotti. October 14, 2024 10:41 am. Published October 14, 2024 10:40 am ...

Abbott (NYSE: ABT) announced today that Health Canada has approved the company's i-STAT TBI test cartridge for use with whole blood, helping clinicians to assess suspected concussion at the ...