Antibody Test Quality Control Kit Atellica® IM SARS-CoV-2 IgG Positive Level / Negative Level 2 X 2 X 2 mL

Features

• The Atellica IM SARS-CoV-2 IgG is for use under Emergency Use Authorization Only: https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-authorizations-medical-devices/in-vitro-diagnostics-euas-serology-and-other-adaptive-immune-response-tests-sars-cov-2 Testing is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA)
• 42 U.S.C 263a
• that meet requirements to perform moderate or high complexity tests The Atellica® IM SARS-CoV-2 IgG Quality Control (sCOVG QC) is for in vitro diagnostic use in monitoring the precision and accuracy of the Atellica® IM SARS-CoV-2 IgG (sCOVG) assay using the Atellica® IM Analyzer Negative results do not preclude acute SARS-CoV-2 infection; if acute infection is suspected
• direct testing for SARS-CoV-2 is necessary Results from antibody testing should not be used to diagnose or exclude acute SARSCoV-2 infection Positive results may be due to past or present infection with non-SARS-CoV-2 coronavirus strains Laboratories within the United States and its territories are required to report all positive results to the appropriate public health authorities 2 vials x 2.0 mL negative control
• 2 vials x 2.0 mL positive control Quality control materials are liquid and ready to use