Siemens Antibody Test Control Kit Atellica IM SARS-CoV-2 Total Positive Level / Negative Level 2 X 2 X 7 mL - M-1167947-2018 | Each

$365.99
Packaging *

Siemens

Control Kit

In Stock

M-1167947-2018

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Item is Non - Returnable

Delivery - 7-10 Days, Ship Directly from Manufacturer

  • Atellica® IM SARS-CoV-2 Total (COV2T) 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
  • Intended for qualitative detection of total antibodies (including IgG and IgM) to SARS-CoV-2 in human serum and plasma (potassium EDTA and lithium heparin) using the Atellica® IM Analyzer
  • Testing is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C 263a, to perform moderate or high complexity tests
  • Atellica IM SARS-CoV-2 Total (COV2T) assay is intended as an aid in identifying patients 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
  • 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 Total (COV2T) 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 Total (COV2T) assay may occur due to cross-reactivity from pre-existing antibodies or other possible causes
  • 2 x 2.0 mL negative quality control, level 1
  • 2 x 2.0 mL positive quality control, level 2

    • Item Id 1167947
    MF ID 11206712
    Brand Atellica® IM
    Manufacturer Siemens
    Application Control Kit
    Container Type Vial
    For Use With For use with Atellica® IM SARS-CoV-2 Total (COV2T) Assay on Atellica® IM Analyzer
    Form Liquid
    Levels Positive Level / Negative Level
    Product Dating McKesson Acceptable Dating: we will ship >= 90 days
    Storage Requirements Requires Refrigeration
    Test Name SARS-CoV-2 Total
    Test Type Antibody Test
    UNSPSC Code 41116145
    Volume 2 X 2 X 7 mL

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