Siemens Reagent Dimension Vista Antibody Test SARS-CoV-2 Total For use with Dimension Vista System 240 Tests - M-1168873-3818 | Kit of 1

$3,742.99
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Siemens

Reagent

In Stock

M-1168873-3818

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Item is Non - Returnable

Delivery - 7-10 Days, Ship Directly from Manufacturer

  • The Dimension Vista® SARS‑CoV‑2 Total antibody assay (COV2T) 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, to perform moderate or high complexity tests
  • 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 Dimension Vista® SARS‑CoV‑2 Total antibody assay (COV2T) 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 Dimension Vista® SARS‑CoV‑2 Total antibody assay (COV2T) may occur due to cross‑reactivity from pre‑existing antibodies or other possible causes
  • The Dimension Vista® SARS‑CoV‑2 Total antibody assay (COV2T) is for in vitro diagnostic use in the qualitative detection of total antibodies (including IgG and IgM) to SARS‑CoV‑2 in human serum and plasma (dipotassium EDTA and lithium heparin) using the Dimension Vista® System
  • This assay is intended as an aid in identifying individuals with an adaptive immune response to SARS‑CoV‑2, indicating recent or prior infection
  • The Dimension Vista® SARS‑CoV‑2 Total antibody assay (COV2T) should not be used to diagnose acute SARS‑CoV‑2 infection
  • 16 minutes time to first result

    • Item Id 1168873
    MF ID 11417414
    Brand Dimension Vista®
    Manufacturer Siemens
    Application Reagent
    Container Type Cartridge
    For Use With For use with Dimension Vista® System
    Number of Tests 240 Tests
    Product Dating McKesson Acceptable Dating: we will ship >= 90 days
    Sample Type Serum / Plasma Sample
    Storage Requirements Requires Refrigeration
    Test Name SARS-CoV-2 Total
    Test Type Antibody Test
    Time To Results 16 Minute Results
    Type Chemiluminescent Immunoassay
    UNSPSC Code 41116020

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