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www.fdanews.com/articles/204954-lighthouse-lab-services-covid-19-test-gets-emergency-use-authorization

Lighthouse Lab Services’ COVID-19 Test Gets Emergency Use Authorization

October 21, 2021

LMSI, which does business as Lighthouse Lab Services, has received the FDA’s Emergency Use Authorization for its CovidNow SARS-CoV-2 assay.

The COVID-19 test is authorized for use with nasopharyngeal, oropharyngeal or nasal samples. It is also authorized for use with the company’s CovidNow Collection Kit with nasal swab samples that are self-collected at home or in a community-based setting by people age 18 and up who have suspected COVID-19 and have been referred by a healthcare provider.

Sample analysis must be done by authorized laboratories designated by Lighthouse Lab Services and certified under the Clinical Laboratory Improvement Amendments of 1988.

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