![]() This test is approved by CLIA, NJDOH and NYDOH. Clarity Laboratory Virokey SARS CoV-2 real time PCR assay for detection of SARS CoV-2 from nasopharyngeal and oropharyngeal specimen was developed and its performance characteristics determined by Clarity Labs.This test is only authorized for the duration of time of the declaration and for the detection of SARSCoV-2 RNS virus and/or diagnosis of COVID-19 infection under section 564 (b)(1) of the act, 21 U.S.C.360bbb-3(b)(1) unless the authorization is terminated or revoked sooner. ![]() This assay is for in vitro diagnostic use under the FDA Emergency Use Authorization (EUA). The agent detected may not be the definite cause of this disease. Positive results do not rule out co-infection with organisms not included in the Thermo Fisher TaqMan 2019-nCoV Assay Kit v1 and TaqMan 2019-nCoV Control Kit v1, TaqPath COVID-19 Combo Kit and/ or Panther Fusion®️ SARS-CoV-2 Assay Kit.
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