Beckman Coulter Reagent Kit Access® Antibody Test SARS-CoV-2 IgM For use with Access Family of Immunoassay Systems 200 Tests - M-1172371-1187 - Kit of 1

$2,575.99
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Beckman Coulter

Reagent Kit

In Stock

M-1172371-1187

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$2,575.99
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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
  • Time-to-first result (approx.): 37 minutes
  • Sample volume: 10uL

    • Item Id 1172371
    MF ID C58957
    Brand Access®
    Manufacturer Beckman Coulter
    Application Reagent Kit
    Container Type Well
    For Use With For use with Access Family of Immunoassay Systems
    Form Liquid
    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 IgM
    Test Type Antibody Test
    Time To Results 37 Minute Results
    Type Two-step Immunocapture Immunoassay
    UNSPSC Code 41116144

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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."