LabGunTM COVID-19 RT-PCR Kit is a real-time reverse transcription polymerase chain reaction(rRT-PCR) test intended for the qualitative detection of nucleic acid from the SARS-CoV-2 innasopharyngeal, or oropharyngeal, anterior nasal and mid-turbinate nasal swabs, as well asnasopharyngeal wash/aspirate or nasal aspirate specimens and sputum, from individualswho are suspected of COVID-19 by their healthcare provider. Testing is limited tolaboratories certified under the Clinical Laboratory Improvement Amendments of 1988

(CLIA), 42 U.S.C. §263a, to perform high complexity tests. Results are for the identification of SARS-CoV-2 RNA.