Ortho Clinical Diagnostics Calibrator Vitros® Anti-SARS-CoV-2 Total 2 X 1 mL For use with Anti-SARS-CoV-2 Total Reagent Pack Test on Vitros ECi / ECiQ (Available End of May 2020) / Vitros 3600 / 5600 / XT7600 Ready-to-Use - M-1165645-2214 - Each

$191.99
Packaging *

Ortho Clinical Diagnostics

Calibrator

In Stock

M-1165645-2214

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$191.99
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Item is Non - Returnable

Delivery - 7-10 Days, Ship Directly from Manufacturer

  • For use under the Food and Drug Administration's Emergency Use Authorization 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 of 1988 (CLIA), 42 U.S.C. section 263a, to perform moderate and high complexity tests
  • VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total test is performed using the VITROS Anti-SARS-CoV-2 Total Reagent Pack and the VITROS Anti-SARS-CoV-2 Total Calibrator on the VITROS ECi/ECiQ/3600 Immunodiagnostic System and the VITROS 5600/XT 7600 Integrated Systems
  • Results are for the detection of total SARS-CoV-2 antibodies; reactive results could occur after infection and can be indicative of acute or recent infection
  • Laboratories within the United States and its territories are required to report all reactive results to the appropriate public health authorities
  • Non-reactive results do not preclude SARS-CoV-2 infection and should not be used as the sole basis for patient management decisions; results must be combined with clinical observations, patient history, and epidemiological information
  • Rx ONLY; For in vitro diagnostic and Laboratory Professional use; For emergency authorization use ONLY
  • Calibrator contains: SARS-CoV-2 antibody negative plasma obtained from donors who were tested individually and who were found to be negative for hepatitis B surface antigen, and for antibodies to hepatitis C virus (HCV) and HIV, using approved methods (enzyme immunoassays)
  • Calibrator contents: 2 vials of VITROS Anti‑SARS-CoV-2 Total Calibrator (anti-SARS-CoV-2 in anti-SARS-CoV-2 negative human plasma with antimicrobial agent, 1 mL)
  • The VITROS Anti‑SARS-CoV-2 Total test uses 80 μL of calibrator for each determination

    • Item Id 1165645
    MF ID 6199923
    Brand Vitros®
    Manufacturer Ortho Clinical Diagnostics
    Application Calibrator
    Container Type Vial
    For Use With For use with Anti-SARS-CoV-2 Total Reagent Pack Test on Vitros ECi / ECiQ (Available End of May 2020) / Vitros 3600 / 5600 / XT7600
    Form Ready-To-Use
    Product Dating McKesson Acceptable Dating: we will ship >= 90 days
    Storage Requirements Requires Refrigeration
    Test Name Anti-SARS-CoV-2 Total
    Test Type Antibody Test
    UNSPSC Code 41116128
    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."