Siemens Reagent Kit Dimension EXL Antibody Test SARS-CoV-2 IgG For Dimension EXL Integrated Chemistry System with LOCI Module 480 Tests - M-1184489-2030 | Kit of 1

$6,393.99
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Siemens

Reagent

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M-1184489-2030

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$6,393.99
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Item is Non - Returnable

Delivery - 7-10 Days, Ship Directly from Manufacturer

  • The Dimension® EXL™ SARS‑CoV‑2 IgG (CV2G) 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 (CLIA) of 1988, 42 U.S.C 263a, that meet requirements to perform moderate or high complexity tests
  • The Dimension® EXL™ SARS‑CoV‑2 IgG (CV2G) assay is a chemiluminescent immunoassay intended for qualitative and semiquantitative detection of IgG antibodies to SARS‑CoV‑2 in human serum and plasma (dipotassium EDTA and lithium heparin) using the Dimension® EXL™ integrated chemistry system with LOCI® Module
  • Laboratories within the United States and its territories are required to report all results to the appropriate public health authorities
  • The sensitivity of the Dimension® EXL™ SARS‑CoV‑2 IgG (CV2G) 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 Dimension® EXL™ SARS‑CoV‑2 IgG (CV2G) assay may occur due to cross-reactivity from pre-existing antibodies or other possible causes
  • Results are for the detection of SARS‑CoV‑2 IgG antibodies; IgG antibodies to SARS‑CoV‑2 are generally detectable in blood several days after initial infection, although the duration of time antibodies are present post‑infection is not well characterized
  • Dimension EXL CV2G Flex Reagent Cartridge: 8 X 60 Tests

    • Item Id 1184489
    MF ID 11417770
    Brand Dimension® EXL™
    Manufacturer Siemens
    Application Reagent Kit
    Container Type Cartridge
    For Use With For Dimension® EXL™ Integrated Chemistry System with LOCI® Module
    Form Liquid
    Number of Tests 480 Tests
    Product Dating McKesson Acceptable Dating: we will ship >= 90 days
    Sample Type Human Serum / Plasma Sample
    Storage Requirements Requires Refrigeration
    Test Name SARS-CoV-2 IgG
    Test Type Antibody Test
    Type Chemiluminescent Immunoassay
    UNSPSC Code 41116010

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