Abbott Reagent Kit AdviseDx Antibody Test SARS-CoV-2 IgM For use with Alinity i System 200 Tests 21 mL - M-1179185-4291 | Kit of 1

$7,559.99
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Abbott

Reagent

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M-1179185-4291

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$7,559.99
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Item is Non - Returnable

Delivery - 7-10 Days, Ship Directly from Manufacturer

  • The AdviseDx SARS-CoV-2 IgM Assay is for use under an FDA EUA only: 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 (CLIA) of 1988, 42 U.S.C 263a, that meet requirements to perform moderate or high complexity tests
  • The AdviseDx SARS-CoV-2 IgM assay is a chemiluminescent microparticle immunoassay (CMIA) intended for the qualitative detection of IgM antibodies to SARS-CoV-2 in human serum, serum separator tube, and plasma (dipotassium EDTA, tripotassium EDTA, lithium heparin, lithium heparin separator tube, sodium heparin)
  • At this time, it is unknown for how long antibodies persist following infection and if the presence of antibodies confers protective immunity; AdviseDx SARSCoV-2 IgM assay should not be used to diagnose acute SARS-CoV-2 infection
  • Laboratories within the United States and its territories are required to report all results to the appropriate public health authorities
  • Negative results do not preclude acute SARSCoV-2 infection; if acute infection is suspected, direct testing for SARS-CoV-2 is necessary
  • False positive results for the AdviseDx SARS-CoV-2 IgM assay may occur due to cross-reactivity from pre-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 IgM assay

    • Item Id 1179185
    MF ID 06R9120
    Brand AdviseDx
    Manufacturer Abbott
    Application Reagent Kit
    Container Type Cartridge
    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 IgM
    Test Type Antibody Test
    Type Chemiluminescent Microparticle Immunoassay (CMIA)
    UNSPSC Code 41116010
    Volume 21 mL

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