Qualigen Therapeutics (QLGN -4.4%) has begun commercial shipments of its FastPack SARS-CoV-2 IgG diagnostic test for COVID-19 antibodies.
This test has been submitted to the FDA for Emergency Use Authorization (EUA), and earlier this month the company submitted an official notification to the FDA of its plans to exercise its right to commence sales, even while the EUA is pending.
The COVID-19 antibody test uses Qualigen’s new FastPack PRO System, a point-of-care diagnostic instrument, and provides results in ~10 minutes.
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