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For Monitoring the Precision and Accuracy of the ADVIA Centaur® SARS-CoV-2 IgG (sCOVG) Assay using the ADVIA Centaur® Systems
Form
Liquid
Levels
Positive Level / Negative Level
Product Dating
SLI Medical Acceptable Dating: we will ship >= 30 days
Storage Requirements
Requires Refrigeration
Test Name
SARS-CoV-2 IgG
Test Type
Antibody Test
UNSPSC Code
41116145
Volume
2 X 2 X 2 mL
Features
The ADVIA Centaur SARS-CoV-2 IgG (sCOVG) assay is only for use under the Food and Drug Administration’s Emergency Use Authorization: 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 ADVIA Centaur® SARS-CoV-2 IgG Quality Control (sCOVG QC) is for in vitro diagnostic use in monitoring the precision and accuracy of the ADVIA Centaur® SARS-CoV-2 IgG (sCOVG) assay using the ADVIA Centaur® systems
The ADVIA Centaur sCOVG QC is for use only with the ADVIA Centaur sCOVG assay
2 vials x 2.0 mL negative control
2 vials x 2.0 mL positive control
This product is for use with a test authorized only for detecting the presence of IgG antibodies against SARS-CoV-2
