Abbott Reagent Kit Alinity i Antibody Test SARS-CoV-2 IgG For use with Alinity i System 200 Tests - M-1166393-2551 | Kit of 1

$2,665.99
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Abbott

Reagent

In Stock

M-1166393-2551

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$2,665.99
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Item is Non - Returnable

Delivery - 7-10 Days, Ship Directly from Manufacturer

  • SARS-CoV-2 IgG test for use with Alinity i is only for use under the Food and Drug Administration’s Emergency Use Authorization: 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 SARS CoV-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 SARS-CoV-2 IgG assay is only for use under the Food and Drug Administration’s Emergency Use Authorization

    • Item Id 1166393
    MF ID 06R9020
    Brand Alinity I
    Manufacturer Abbott
    Application Reagent Kit
    Container Type Vial
    For Use With For use with Alinity™ i System
    Number of Tests 200 Tests
    Product Dating McKesson Acceptable Dating: we will ship >= 90 days
    Sample Type Human Serum / Plasma Sample
    Storage Requirements Requires Refrigeration
    Test Name SARS-CoV-2 IgG
    Test Type Antibody Test
    Type Chemiluminescent Microparticle Immunoassay (CMIA)
    UNSPSC Code 41116020

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