Abbott Reagent Kit Abbott Antibody Test SARS-CoV-2 IgG For use with Architect i System 100 Tests - M-1164346-2162 | Kit of 100

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Abbott

Reagent

In Stock

M-1164346-2162

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Item is Non - Returnable

Delivery - 7-10 Days, Ship Directly from Manufacturer

  • The SARS-CoV-2 IgG assay 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 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
  • Kit contents include: (100) Tests, 6.6 mL Microparticles, 5.8 mL Conjugate, 7.9 mL Assay Diluent

  • Item Id 1164346
    MF ID 06R8620
    Brand Abbott
    Manufacturer Abbott
    Application Reagent Kit
    Container Type Vial
    For Use With For use with Architect i System
    Number of Tests 100 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 41116010

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