Siemens 11207386 - Immunoassay Reagent… | USA MedPremium
Immunoassay Reagent Atellica® IM SARS-CoV-2 IgG For Atellica IM Analyzer 100 Tests
USAMP#31909036SKU: 11207386Atellica® IM
Product Spotlight
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
Negative results do not preclude acute SARS-CoV-2 infection; if acute infection is suspected, direct testing for SARS-CoV-2 is necessary
Laboratories within the United States and its territories are required to report all positive results to the appropriate public health authorities
Positive results may be due to past or present infection with non-SARS-CoV-2 coronavirus strains
The Atellica® IM SARS-CoV-2 IgG (sCOVG) assay is a chemiluminescent immunoassay intended for the qualitative and semi-quantitative detection of IgG antibodies, including neutralizing antibodies, to SARS-CoV-2 in human serum and plasma (lithium heparin) using the Atellica® IM Analyzer
Contents: 1 ReadyPack primary reagent pack containing Atellica sCOVG Lite Reagent, Solid Phase, and Ancillary Well Reagent, 1 ReadyPack ancillary reagent pack containing Atellica sCOVG DIL, Atellica IM sCOVG master curve and test definition, 1 vial sCOVG low calibrator, 1 vial sCOVG high calibrator, sCOVG calibrator assigned value sheet
Results from antibody testing should not be used to diagnose or exclude acute SARSCoV-2 infection
