Molecular Diagnostic / Real-Time RT-PCR Control Lyra® SARS-CoV-2 Negative Level 1 mL

Features

• Lyra SARS-CoV-2 Assay is authorized for use under an FDA EUA: https://www.fda.gov/medical-devices/emergency-situations-medical-devices/emergency-use-authorizations
• Lyra SARS-CoV-2 Assay is for use only under EUA in United States (U.S.) laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, to perform high complexity tests
• The Lyra SARS-CoV-2 Assay is a qualitative test for the detection of nucleic acid from SARSCoV-2 in NP and OP swab specimens obtained from patients suspected of COVID-19 by their healthcare provider
• Positive results are indicative of the presence of SARS-CoV-2 RNA; clinical correlation with patient history and other diagnostic information is necessary to determine patient infection status - positive results do not rule out bacterial infection or co-infection with other viruses
• Negative results do not preclude SARS-CoV-2 infection and should not be used as the sole basis for patient management decisions; negative results must be combined with clinical observations, patient history, and epidemiological information