Ortho Clinical Diagnostics Calibrator Kit Vitros® Anti-SARS-CoV-2 IgG 2 X 1 mL For use with Anti-SARS-CoV-2 IgG Test on Vitros ECi / ECiQ (Available End of May 2020) / Vitros 3600 / 5600 / XT7600 Liquid - M-1166247-1329 - Each

$191.99
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Ortho Clinical Diagnostics

Calibrator Kit

In Stock

M-1166247-1329

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$191.99
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Item is Non - Returnable

Delivery - 7-10 Days, Ship Directly from Manufacturer

  • The VITROS Anti-SARS-CoV-2 IgG test 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. section 263a, to perform moderate and high complexity tests
  • Laboratories within the United States and its territories are required to report all positive results to the appropriate public health authorities
  • The sensitivity of VITROS Anti-SARS-CoV-2 IgG test in early infection is unknown; 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 VITROS Anti-SARS-CoV-2 IgG test may occur due to cross-reactivity from pre-existing antibodies or other possible causes
  • VITROS Anti-SARS-CoV-2 IgG test 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
  • VITROS Anti-SARS-CoV-2 IgG test should not be used to diagnose acute SARS-CoV-2 infection
  • VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Reagent Pack when used in combination with the VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Calibrator is a chemiluminescent immunoassay test intended for the qualitative detection of IgG antibodies to SARS-CoV-2 in human serum
  • VITROS Anti‑SARS-CoV-2 IgG Calibrator is suitable for use until the expiration date on the carton when stored and handled as specified; do not use beyond the expiration date
  • The VITROS Anti‑SARS-CoV-2 IgG test uses 20 μL of calibrator for each determination
  • VITROS Anti‑SARS-CoV-2 IgG Calibrator is supplied ready to use

    • Item Id 1166247
    MF ID 6199920
    Brand Vitros®
    Manufacturer Ortho Clinical Diagnostics
    Application Calibrator Kit
    Container Type Vial
    For Use With For use with Anti-SARS-CoV-2 IgG Test on Vitros ECi / ECiQ (Available End of May 2020) / Vitros 3600 / 5600 / XT7600
    Form Liquid
    Product Dating McKesson Acceptable Dating: we will ship >= 90 days
    Storage Requirements Requires Refrigeration
    Test Name Anti-SARS-CoV-2 IgG
    Test Type Antibody Test
    UNSPSC Code 41116145
    Volume 2 X 1 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."