Uh-Oh Labs Dx Pro guides users through the process of running the the UOL COVID-19 Test and presents test results in plain, easy-to-understand language.
The UOL COVID-19 Test requires the Uh-Oh Labs Dx Pro app and includes the UOL COVID-19 Instrument and UOL COVID-19 Test Kit, available at www.uhohlabs.com.
The UOL COVID-19 Test can detect COVID within 40 minutes with a 96.1% overall accuracy compared to PCR with no false positives.
The UOL COVID-19 Test is intended for use by trained operators who are proficient in performing tests with the UOL COVID-19 Test, and is only for use under the Food and Drug Administration’s Emergency Use Authorization.
The UOL COVID-19 Test is intended for the qualitative detection of nucleic acid from SARS-CoV-2, the virus that causes COVID-19, from individuals suspected of COVID-19 by a healthcare provider. Testing is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, that meet requirements to perform high, moderate, or waived complexity tests. The UOL COVID-19 Test is authorized for use at the Point of Care (PoC), i.e., in patient care settings operating under a CLIA Certificate of Waiver, Certificate of Compliance, or Certificate of Accreditation.
Results from the UOL COVID-19 Test should not be used as the sole basis for treatment or other patient management decisions and must be combined with clinical observations, patient history, and/or epidemiological information.