Home / Clinical Laboratory / Controls / Control Kit / Antibody Test Control Kit Abbott SARS-CoV-2 IgG Positive Level / Negative Level 2 X 4 mL06R8610
Picture of Antibody Test Control Kit Abbott SARS-CoV-2 IgG Positive Level / Negative Level 2 X 4 mL06R8610

Antibody Test Control Kit Abbott SARS-CoV-2 IgG Positive Level / Negative Level 2 X 4 mL06R8610

Antibody-Test-Control-Kit-Abbott-SARS-CoV-2-IgG-Positive-Level--Negative-Level-2-X-4-mL06R8610

SKU #

#1164348

MPN #

06R8610

Brand

Abbott

Stock

In Stock

Quantity

100

Features

CONTROL, ARCH SARS-COV-2 IGG D/S

$150.00 USD

Attribute Name Attribute Value
McKesson # 1164348
Manufacturer # 06R8610
Brand Abbott
Manufacturer Abbott
Application Control Kit
For Use With For Estimation of Test Precision and the Detection of Systematic Analytical Deviations of the Architect i System when used for the Qualitative Detection of IgG Antibodies to SARS-CoV-2 in Human Serum and Plasma
Levels Positive Level / Negative Level
Product Dating McKesson Acceptable Dating: we will ship >= 90 days
Storage Requirements Requires Refrigeration
Test Name SARS-CoV-2 IgG
Test Type Antibody Test
UNSPSC Code 41116128
Volume 2 X 4 mL

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  • For In Vitro use; Rx only
  • For use under an Emergency Use Authorization (EUA) Only : https://www.fda.gov/medical-devices/emergency-situations-medical-devices/emergency-use-authorizations
  • The SARS-CoV-2 IgG assay is intended for use as an aid in identifying individuals with an adaptive immune response to SARS-CoV-2, indicating recent or prior infection; at this time, it is unknown for how long antibodies persist following infection and if the presence of antibodies confers protective immunity
  • The SARSCoV-2 IgG assay should not be used to diagnose acute SARS-CoV-2 infection
  • Testing is limited to laboratories certified under the Clinical Laboratory Improvement Amendments (CLIA) of 1988, 42 U.S.C 263a, to perform moderate or high complexity test
  • Laboratories within the United States and its territories are required to report all positive results to the appropriate public health authorities
  • 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 SARS-CoV-2 IgG assay may occur due to cross-reactivity from pre-existing antibodies or other possible causes
  • The human-sourced materials used in the controls have been tested and found to be reactive for anti-SARS-CoV-2 IgG and nonreactive for HBsAg, HIV-1 RNA or HIV-1 Ag, anti-HIV-1/HIV-2, and anti-HCV
  • 1 X 4 mL negative control; 1 X 4 mL positive control