RT-PCR Control Kit Accula™ SARS-CoV-2 Low Positive / High Positive / Negative Level 3 X 3 Swabs

Features

• Emergency Use Authorization (EUA) only: https:www.fda.gov/medical-devices/emergency-situations-medical-devices/emergency-use-authorizations Product ships with minimum 30 days dating Testing is authorized for laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA)
• 42 U.S.C. §263a
• to perform high and moderate complexity tests The Accula SARS-CoV-2 Test using nasal swab specimens is also authorized to be distributed and used in patient care settings outside of the clinical laboratory environment Accula SARS-CoV-2 Test results are for the identification of SARS-CoV-2 RNA; the SARS-CoV-2 RNA is generally detectable in nasal swab specimens during the acute phase of infection 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 Testing facilities within the United States and its territories are required to report all positive results to the appropriate public health authorities 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 The Accula SARS-CoV-2 Test is intended for use by trained operators who are proficient in performing tests on the Accula Dock and Silaris Dock; the Accula SARS-CoV-2 Test is only for use under the Food and Drug Administration’s Emergency Use Authorization 9 Control swabs: 3 Sets of Controls (High Positive
• Low Positive
• Negative)