Siemens Antibody Test Quality Control Atellica IM SARS-CoV-2 IgG Positive Level / Negative Level 4 X 2 mL - M-1173394-4609 | Kit of 1

$365.99
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Siemens

Quality Control

In Stock

M-1173394-4609

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Item is Non - Returnable

Delivery - 7-10 Days, Ship Directly from Manufacturer

  • Atellica® IM SARS-CoV-2 IgG (COV2G) 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
  • 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
  • Atellica IM 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 Atellica IM 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 Atellica IM SARS-CoV-2 IgG (COV2G) assay may occur due to crossreactivity from pre-existing antibodies or other possible causes
  • 2 X 2 mL positive control
  • 2 X 2 mL negative control

    • Item Id 1173394
    MF ID 11206999
    Brand Atellica® IM
    Manufacturer Siemens
    Application Quality Control
    Container Type Vial
    For Use With For use with Atellica® IM SARS-CoV-2 IgG (COV2G) Assay on Atellica® IM Analyzer
    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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