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Quidel Subsidiary Lands First De Novo Clearance For COVID-19 Serology Tests

 
• By Elizabeth Orr

VITROS COVID-19 tests from Ortho-Clinical Diagnostics have been cleared by the US FDA, establishing regulatory pathway for future similar tests.

angellodeco/Shutterstock.com

The US Food and Drug Administration announced today that it has granted de novo authorization to two COVID-19 tests developed by QuidelOrtho Corporation subsidiary Ortho Clinical Diagnostics, making them the first serology tests for the virus to win full clearance from the FDA.

The products are the VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Reagent Pack and the VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total Reagent Pack, both of which are used with the VITROS Immunodiagnostic Products...

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