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Picture of Reagent Kit Alinity i Antibody Test SARS-CoV-2 IgG For use with Alinity™ i System 1,000 Tests06R9030

Reagent Kit Alinity i Antibody Test SARS-CoV-2 IgG For use with Alinity™ i System 1,000 Tests06R9030

Reagent-Kit-Alinity-i-Antibody-Test-SARS-CoV-2-IgG-For-use-with-Alinity™-i-System-1,000-Tests06R9030

SKU #

#1166392

MPN #

06R9030

Brand

Abbott

Stock

In Stock

Quantity

100

Features

REAGENT, ALINITY I SARS-COV-2 IGG (1000TEST/KT) D/S

$6,771.23 USD

Product Specifications Product Usage Additional Information
Print
Attribute Name Attribute Value
McKesson # 1166392
Manufacturer # 06R9030
Brand Alinity I
Manufacturer Abbott
Application Reagent Kit
Container Type Vial
For Use With For use with Alinity™ i System
Number of Tests 1,000 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 41116020
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  • SARS-CoV-2 IgG test for use with Alinity i 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 SARS CoV-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
  • The SARS-CoV-2 IgG assay is only for use under the Food and Drug Administration’s Emergency Use Authorization