Qualigen to sell SARS-CoV-2 test in U.S. in July

LabPulse.com staff writers
Jun 30, 2020
2019 11 08 17 54 6978 News Ball 400

Qualigen Therapeutics notified the U.S. Food and Drug Administration (FDA) that it will begin selling its SARS-CoV-2 antibody test in the U.S. this month.

The notification allows Qualigen to sell its FastPack SARS-CoV-2 immunoglobulin G (IgG) test while the FDA considers granting its request for an emergency use authorization for the product. The company expects sales and shipments of the test to start in mid-July.

The test is a chemiluminescent microparticle test intended for the qualitative detection of SARS-CoV-2 IgG antibodies in blood to identify individuals with an adaptive immune response to the virus that causes COVID-19. Results are delivered in fewer than 10 minutes, according to Qualigen.

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