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Immunoassay Calibrator Alinity i Dehydroepiandrosterone Sulfate (DHEA-S) 6 X 2 mL For Alinity i Analyzers Ready-to-Use Liquid
Calibrator Kit AdviseDx SARS-CoV-2 IgG II 6 X 2 mL For the Calibration of the ARCHITECT i Systems when used for the Qualitative and Semi-Quantitative Detection of IgG Antibodies to SARS-CoV-2 in Human Serum
For the Calibration of the ARCHITECT i System when used for the Qualitative and Semi-Quantitative Detection of IgG Antibodies to SARS-CoV-2 in Human Serum
Levels
Level A
Product Dating
B
Storage Requirements
C
Test Name
D
Test Type
E
UNSPSC Code
F
Volume
SLI Medical Acceptable Dating: we will ship >= 30 days
Keep Frozen
SARS-CoV-2 IgG II
Antibody Test
41116145
6 X 2 mL
Features
The AdviseDx SARS-CoV-2 IgG II 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
Testing is limited to laboratories certified under the Clinical Laboratory Improvement Amendments (CLIA) of 1988
42 U.S.C 263a
that meet requirements to perform moderate or high complexity tests
Laboratories within the United States and its territories are required to report all results to the appropriate public health authorities
The AdviseDx SARS-CoV-2 IgG II Calibrator Kit is for the calibration of the ARCHITECT i System when used for the qualitative and semi-quantitative detection of IgG antibodies to SARS-CoV-2 in human serum (including collected using a serum separator tube) and plasma (acid citrate dextrose
sodium citrate
dipotassium EDTA
tripotassium EDTA
lithium heparin
lithium heparin in a separator tube
and sodium heparin)
At this time
it is unknown for how long antibodies persist following infection and if the presence of antibodies confers protective immunity
The AdviseDx SARS-CoV-2 IgG II assay should not be used to diagnose or exclude acute SARS-CoV-2 infection
Negative results do not preclude acute SARS-CoV-2 infection; if acute infection is suspected
direct testing for SARS-CoV-2 is necessary
False positive results for the AdviseDx SARS-CoV-2 IgG II assay may occur due to cross-reactivity from pre-existing antibodies or other possible causes
Due to the risk of false positive results
confirmation of positive results should be considered using a second
different IgG assay
Calibrator A contains phosphate buffer and protein (bovine) stabilizer
Calibrators B through F contain anti-SARS-CoV-2 IgG (human
monoclonal) in phosphate buffer with protein (bovine) stabilizer
Calibrator Kit AdviseDx SARS-CoV-2 IgG II 6 X 2 mL For the Calibration of the ARCHITECT i Systems when used for the Qualitative and Semi-Quantitative Detection of IgG Antibodies to SARS-CoV-2 in Human Serum
