Home / Clinical Laboratory / Clinical Analyzer Calibrators and Reagents / Reagents / Reagent Kit / Reagent Kit Abbott Antibody Test SARS-CoV-2 IgG For use with Architect i System 100 Tests06R8620
Picture of Reagent Kit Abbott Antibody Test SARS-CoV-2 IgG For use with Architect i System 100 Tests06R8620

Reagent Kit Abbott Antibody Test SARS-CoV-2 IgG For use with Architect i System 100 Tests06R8620

Reagent-Kit-Abbott-Antibody-Test-SARS-CoV-2-IgG-For-use-with-Architect-i-System-100-Tests06R8620

SKU #

#1164346

MPN #

06R8620

Brand

Abbott

Stock

In Stock

Quantity

100

Features

REAGENT, ARCH SARS-COV-2 IGG (100/KT) D/S

$649.99 USD

Attribute Name Attribute Value
McKesson # 1164346
Manufacturer # 06R8620
Brand Abbott
Manufacturer Abbott
Application Reagent Kit
Container Type Vial
For Use With For use with Architect i System
Number of Tests 100 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 Microparticle Immunoassay (CMIA)
UNSPSC Code 41116010

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  • The SARS-CoV-2 IgG 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
  • The SARS-CoV-2 IgG assay 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
  • The SARSCoV-2 IgG assay should not be used to diagnose acute SARS-CoV-2 infection
  • Testing is limited to laboratories certified under the Clinical Laboratory Improvement Amendments (CLIA) of 1988, 42 U.S.C 263a, to perform moderate or high complexity test
  • 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 SARS-CoV-2 IgG assay may occur due to cross-reactivity from pre-existing antibodies or other possible causes
  • Kit contents include: (100) Tests, 6.6 mL Microparticles, 5.8 mL Conjugate, 7.9 mL Assay Diluent