Home / Clinical Laboratory / Controls / Quality Control Kit / Antibody Test Quality Control Kit Atellica® IM SARS-CoV-2 IgG Positive Level / Negative Level 2 X 2 X 2 mL11207388
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Antibody Test Quality Control Kit Atellica® IM SARS-CoV-2 IgG Positive Level / Negative Level 2 X 2 X 2 mL11207388

Antibody-Test-Quality-Control-Kit-Atellica®-IM-SARS-CoV-2-IgG-Positive-Level--Negative-Level-2-X-2-X-2-mL11207388

SKU #

#1185715

MPN #

11207388

Brand

Siemens

Stock

In Stock

Quantity

100

Features

CONTROL, ATELLICA IM SARS-COV--2 IGG QC 2X2X2ML D/S

$178.80 USD

Product Specifications Product Usage Additional Information
Print
Attribute Name Attribute Value
McKesson # 1185715
Manufacturer # 11207388
Brand Atellica® IM
Manufacturer Siemens
Application Quality Control Kit
Container Type Vial
For Use With For Monitoring Precision and Accuracy of the Atellica® IM SARS-CoV-2 IgG (sCOVG) Assay using the Atellica® IM Analyzer
Form Liquid
Levels Positive Level / Negative Level
Product Dating McKesson 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
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  • 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