Siemens Antibody Test Quality Control ADVIA Centaur SARS-CoV-2 IgG Positive Level / Negative Level 4 X 2 mL - M-1173391-1708 | Kit of 1

$365.99
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Siemens

Quality Control

In Stock

M-1173391-1708

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Item is Non - Returnable

Delivery - 7-10 Days, Ship Directly from Manufacturer

  • SARS-CoV-2 IgG (COV2G) is ONLY for use under FDA 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 ADVIA Centaur SARS-CoV-2 IgG (COV2G) 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
  • The ADVIA Centaur SARS-CoV-2 IgG (COV2G) 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 positive results to the appropriate public health authorities
  • The sensitivity of the ADVIA Centaur SARS-CoV-2 IgG (COV2G) assay early after 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 the ADVIA Centaur SARS-CoV-2 IgG (COV2G) assay may occur due to cross-reactivity from pre-existing antibodies or other possible causes
  • 2 X 2 ml positive control
  • 2 X 2 ml negative control

    • Item Id 1173391
    MF ID 11206994
    Brand ADVIA Centaur®
    Manufacturer Siemens
    Application Quality Control
    Container Type Vial
    For Use With For use with the SARS-CoV-2 IgG Assay on the ADVIA Centaur XP and ADVIA Centaur XPT Systems
    Levels Positive Level / Negative Level
    Product Dating McKesson Acceptable Dating: we will ship >= 30 days
    Storage Requirements Requires Refrigeration
    Test Name SARS-CoV-2 IgG
    Test Type Antibody Test
    UNSPSC Code 41116145
    Volume 4 X 2 mL

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