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Clinical Trial 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 predicate and satisfies the statutory criteria for Clinical Laboratory Improvement Amendments (CLIA) waiver.


Clinical Trial Description

n/a


Study Design


Related Conditions & MeSH terms


NCT number NCT05928507
Study type Observational [Patient Registry]
Source Baebies, Inc.
Contact Candice Prowse
Phone 7038632530
Email clinical@baebies.com
Status Not yet recruiting
Phase
Start date October 2, 2023
Completion date March 30, 2024