Ortho Clinical Diagnostics Antibody Test Control Vitros® Anti-SARS-CoV-2 Total Positive Level / Negative Level 3 X 1 mL - M-1165646-4732 - Each

$628.99
Packaging *

Ortho Clinical Diagnostics

Control

In Stock

M-1165646-4732

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Item is Non - Returnable

Delivery - 7-10 Days, Ship Directly from Manufacturer

  • For use under an Emergency Use Authorization (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 of 1988 (CLIA), 42 U.S.C. section 263a, to perform moderate and high complexity tests
  • 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
  • VITROS Anti‑SARS-CoV-2 Total Controls 1 and 2 contain: 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)
  • VITROS Anti‑SARS-CoV-2 Total Control 2 in addition contains: SARS-CoV-2 antibody; handle as if capable of transmitting infection
  • Includes: 3 sets of VITROS Anti-SARS-CoV-2 Total Controls 1 and 2 (human matrix with anti-microbial agent, 1 mL)ARS-CoV-2 Total Control 2 in addition contains: SARS-CoV-2 antibody; handle as if capable of transmitting infection
  • Supplied ready-to-use

    • Item Id 1165646
    MF ID 6199924
    Brand Vitros®
    Manufacturer Ortho Clinical Diagnostics
    Application Control
    Container Type Vial
    For Use With For use in Monitoring the Performance of Vitros ECi / ECiQ (Available End of May 2020) / Vitros 3600 / 5600 / XT7600 when used for the Determination of Antibodies to SARS-CoV-2
    Levels Positive Level / Negative Level
    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 3 X 1 mL

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