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Picture of Reagent Dimension Vista® Antibody Test SARS-CoV-2 Total For use with Dimension Vista® System 240 Tests11417414

Reagent Dimension Vista® Antibody Test SARS-CoV-2 Total For use with Dimension Vista® System 240 Tests11417414

Reagent-Dimension-Vista®-Antibody-Test-SARS-CoV-2-Total-For-use-with-Dimension-Vista®-System-240-Tests11417414

SKU #

#1168873

MPN #

11417414

Brand

Siemens

Stock

In Stock

Quantity

100

Features

REAGENT, VISTA COV2T (240TEST/KT) D/S

$1,787.96 USD

Product Specifications Product Usage Additional Information
Print
Attribute Name Attribute Value
McKesson # 1168873
Manufacturer # 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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  • 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