Delphine PrecisQT™ COVID-19 Test Kit DDX101

Delphine PrecisQT™ COVID-19 test kit is a real-time reverse transcription polymerase chain reaction (RT-PCR) test intended to detect the SARS-CoV-2 infection in nasopharyngeal and oropharyngeal swabs sampled from individuals who are suspected of having COVID-19 by their healthcare provider. Testing is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, to perform high complexity tests.

A notification of the Intent to distribute the Delphine PrecisQT™ COVID-19 Test Kit has been accepted by the FDA’s Center for Devices and Radiological Health (CDRH) under Section IV.C.2 of the FDA’s Policy for Coronavirus Disease-2019 Tests During the Public Health Emergency (Revised) | FDA. Review of the validation of the Delphine PrecisQT™ COVID-19 Test Kit has not been completed by FDA. The Delphine listing under the policy can be found at: Notifications and Emergency Use Authorizations: FAQs on Testing for SARS-CoV-2 | FDA

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