Beckman Coulter Calibrator Access® SARS-CoV-2 IgM 2 X 2 mL For use in Calibration of Access SARS-CoV-2 IgM Assay on Access Family of Immunoassay Systems only Liquid - M-1172372-2205 - Box of 1

$492.99
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Beckman Coulter

Calibrator

In Stock

M-1172372-2205

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$492.99
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Item is Non - Returnable

Delivery - 7-10 Days, Ship Directly from Manufacturer

  • The Access SARS-CoV-2 IgM Assay is only for use under the FDA's Emergency Use Authorization: https://www.fda.gov/medical-devices/emergency-situations-medical-devices/emergency-use-authorizations
  • Testing is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, that meet requirements to perform moderate or high complexity tests
  • Access SARS%XE2%X80?CoV%XE2%X80?2 IgM is a paramagnetic particle, chemiluminescent immunoassay intended for the qualitative detection of IgM antibodies to SARS%XE2%X80?CoV%XE2%X80?2 in human serum, serum separator tubes and plasma (lithium heparin, dipotassium EDTA, tripotassium EDTA, sodium citrate)
  • Access SARS%XE2%X80?CoV%XE2%X80?2 IgM is intended for use as an aid in identifying individuals with an adaptive immune response to SARS%XE2%X80?CoV%XE2%X80?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.
  • Laboratories within the United States and its territories are required to report all results to the appropriate public health authorities
  • The sensitivity of the Access SARS-CoV-2 IgM assay early after infection is unknown; negative results do not preclude acute SARS-CoV-2 infection
  • False positive results for the Access SARS%XE2%X80?CoV%XE2%X80?2 IgM assay may occur due to cross%XE2%X80?reactivity from pre%XE2%X80?existing antibodies or other possible causes; due to the risk of false positive results, confirmation of positive results should be considered using a second different assay
  • The Access SARS-CoV-2 IgM Calibrators are intended to calibrate the Access SARS-CoV-2 IgM assay for the in vitro qualitative detection of SARS-CoV-2 IgM antibodies in human serum, serum separator tubes and plasma (lithium heparin, dipotassium EDTA, tripotassium EDTA, sodium citrate) for use on the Access Family of Immunoassay Systemsonly
  • The Access SARS-CoV-2 IgM Calibrators are provided as: negative and positive; assay calibration data are valid up to 28 days
  • Provided ready to use

    • Item Id 1172372
    MF ID C58958
    Brand Access®
    Manufacturer Beckman Coulter
    Application Calibrator
    Container Type Vial
    For Use With For use in Calibration of Access SARS-CoV-2 IgM Assay on Access Family of Immunoassay Systems only
    Form Liquid
    Levels Level 1, 2
    Product Dating McKesson Acceptable Dating: we will ship >= 30 days
    Storage Requirements Requires Refrigeration
    Test Name SARS-CoV-2 IgM
    Test Type Antibody Test
    UNSPSC Code 41116145
    Volume 2 X 2 mL

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    FDA Disclaimer: "These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease."