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LABDX COVID-19 PCR test has been authorized by the FDA under an Emergency Use Authorization (EUA) for qualitative detection of nucleic acid through real-time polymerase chain reaction (RT-PCR) from SARS-CoV-2 in upper respiratory samples during the acute phase of the infection of COVID- 19, not for any other viruses or pathogens. The test is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostic tests for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.
LABDX is providing testing based on tests from various manufacturers. Such tests have either received an Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) or were released for use under FDA guidance. Tests being performed under an EUA have not been FDA cleared or approved and LabDX has completed independent validation of these tests. In addition, various manufacturers have submitted or will seek EUA for their tests.
The cash price for a PCR test is $290 for tests reported within 2 calendar days.
South Florida's #1 COVID-19 & Drug Testing Solution