Product details

This test was developed, its performance characteristics determined, and testing performed by DxTerity Diagnostics Inc. located at ****0 S. Rancho Way, Suite **6, Rancho Dominguez, CA ****0, regulated under the Clinical Laboratory Improvement Amendments of ***8 (CLIA), *2U.S.C. as qualified to perform high complexity clinical testing. This test has not been FDA cleared or approved. This test has been authorized by FDA under an Emergency Use Authorization (EUA) for use by DxTerity Diagnostics, Inc. This test has been authorized only for the qualitative detection of nucleic acid from SARS-CoV*2 virus that causes COVID**9, not for any other viruses or pathogens. This test is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of COVID**9 under Section **4(b)(1) of the Act, *1 U.S.C. § **0bbb*3(b)(1), unless the authorization is terminated or revoked sooner. Results of the test should not be used as the sole basis for patient management decisions. A positive test result indicates that SARS-CoV*2 virus was detected. A negative test result does not exclude SARS-CoV*2 infection. An indeterminate test result indicates that viral detection could not be reliably determined for the specimen and that additional specimen collection for testing is recommended.