Beckman Coulter Antibody Test Quality Control Access® SARS-CoV-2 IgG Positive Level / Negative Level 3 X 4 mL - M-1167488-2428 - Box of 1

$785.99
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Beckman Coulter

Quality Control

In Stock

M-1167488-2428

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$785.99
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Item is Non - Returnable

Delivery - 7-10 Days, Ship Directly from Manufacturer

  • The Access 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
  • 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
  • The Access 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
  • 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 the Access SARS-CoV-2 IgG assay may occur due to cross-reactivity from pre-existing antibodies or other possible causes
  • Provided ready to use
  • Refer to the QC value card for mean values and standard deviations (SD)
  • QC1: Negative: TRIS buffer, defibrinated human plasma negative for anti-SARS-CoV-2 surfactant and protein (bovine), < 0.1% sodium azide and 0.5% ProClin 300
  • QC2: Positive: TRIS buffer, defibrinated human plasma containing anti-SARS-CoV-2 IgG, surfactant and protein (bovine), < 0.1% sodium azide and 0.5% ProClin 300

    • Item Id 1167488
    MF ID C58964
    Brand Access®
    Manufacturer Beckman Coulter
    Application Quality Control
    Container Type Vial
    For Use With For Monitoring Performance of Access SARS-CoV-2 IgG Assay on the Access Family of Immunoassay Systems
    Levels Positive Level / Negative Level
    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 41116145
    Volume 3 X 4 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."