Abbott Calibrator Kit Abbott SARS-CoV-2 IgG 1 X 2.0 mL For the Calibration of the Architect i System when used for the Qualitative Detection of IgG Antibodies to SARS-CoV-2 in Human Serum and Plasma - M-1164347-1900 - Each

$191.99
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Abbott

Calibrator Kit

In Stock

M-1164347-1900

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$191.99
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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
  • 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
  • Contains inactivated, cell-free, human blood-derived material, reactive for anti-SARS-CoV-2 IgG
  • Preservatives: sodium azide and antimicrobial agents
  • Prescription Use only; For In Vitro Diagnostic Use Only

    • Item Id 1164347
    MF ID 06R8601
    Brand Abbott
    Manufacturer Abbott
    Application Calibrator Kit
    For Use With For the Calibration of the Architect i System when used for the Qualitative Detection of IgG Antibodies to SARS-CoV-2 in Human Serum and Plasma
    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 1 X 2.0 mL

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