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Picture of Reagent Kit Vidas® Antibody Test SARS-COV-2 IgG For use with Instruments of the VIDAS Family 60 Tests423834-01

Reagent Kit Vidas® Antibody Test SARS-COV-2 IgG For use with Instruments of the VIDAS Family 60 Tests423834-01

Reagent-Kit-Vidas®-Antibody-Test-SARS-COV-2-IgG-For-use-with-Instruments-of-the-VIDAS-Family-60-Tests423834-01

SKU #

#1168570

MPN #

423834-01

Brand

Biomerieux

Stock

In Stock

Quantity

100

Features

REAGENT KIT, VIDAS SARS-COV-2 IGG (60T/KT) D/S

$538.49 USD

Product Specifications Product Usage Additional Information
Print
Attribute Name Attribute Value
McKesson # 1168570
Manufacturer # 423834-01
Brand VIDAS®
Manufacturer Biomerieux
Application Reagent Kit
For Use With For use with Instruments of the VIDAS Family
Form Reagent Strip
Number of Tests 60 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 Enzyme Linked Fluorescent Assay
UNSPSC Code 41116020
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  • VIDAS® SARS-COV-2 IgG Assay is for use under an Emergency Use Authorization (EUA) only: 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
  • The VIDAS® SARS-COV-2 IgG is an automated assay using the ELFA (Enzyme Linked Fluorescent Assay) technique intended for qualitative detection of IgG antibodies to SARS-CoV-2 in human serum or plasma (lithium heparin) on instruments of the VIDAS family
  • The VIDAS® SARS‑COV‑2 IgG is 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
  • Laboratories within the United States and its territories are required to report all positive results to the appropriate public health authorities
  • 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 VIDAS® SARS‑COV‑2 IgG may occur due to cross‑reactivity from pre‑existing antibodies or other possible causes
  • Kit contains: 60 Strips (9COM), 60 Solid Phase Receptacles(9COG) 2 x 30, Standard (9COG) 1 X 0.5 mL (liquid), Positive control (9COG) 1 x 0.5 mL (liquid), Negative Control 1 X 0.5 mL (liquid), and package insert