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www.fdanews.com/articles/205726-auderes-healthpulsehome-covid-19-test-gets-fdas-emergency-use-authorization

Audere’s HealthPulse@home COVID-19 Test Gets FDA’s Emergency Use Authorization

December 10, 2021

The FDA has issued an Emergency Use Authorization to Seattle, Wash.-based Audere for its HealthPulse@home COVID-19 test collection kit.

Nasal swab samples collected at home using the kit are shipped at ambient temperature for testing in a laboratory.

If present in the sample, RNA from the SARS-CoV-2 virus that causes COVID-19 infection is detected using an approved molecular diagnostic test.

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