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First received: June 26, 2023

Clinical Trial: FINDER® Instrument and FINDER® FLU A/B, RSV, SARS-CoV-2 Test Clinical Evaluation Protocol

Study Status: NOT_YET_RECRUITING

Recruit Status: NOT_YET_RECRUITING

Condition: Influenza A

Study Type: OBSERVATIONAL


Official Title: CSP0010 FINDER® Instrument and FINDER® FLU A/B, RSV, SARS-CoV-2 Test Clinical Evaluation Protocol

Brief Summary: The goal of this observational study is to compare the FINDER FLU A/B, RSV, SARS-CoV-2 Test to an FDA-cleared device.The study will utilize prospectively collected de-identified nasopharyngeal samples obtained from both pediatric and adult populations from subjects presenting with symptoms of respiratory illness.The main question it aims to answer are:• the study is to validate that the device intended use in terms that the device's performance meets the criteria for substantial equivalence with a…

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