Abbott Antibody Test Control Kit Abbott SARS-CoV-2 IgG Positive Level / Negative Level 2 X 4 mL - M-1164348-1566 - Each

$270.99
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Abbott

Control Kit

In Stock

M-1164348-1566

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$270.99
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Item is Non - Returnable

Delivery - 7-10 Days, Ship Directly from Manufacturer

  • 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

    • Item Id 1164348
    MF ID 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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