Home / Clinical Laboratory / Controls / Quality Control / Antibody Test Quality Control Atellica® IM SARS-CoV-2 IgG Positive Level / Negative Level 4 X 2 mL11206999
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Antibody Test Quality Control Atellica® IM SARS-CoV-2 IgG Positive Level / Negative Level 4 X 2 mL11206999

Antibody-Test-Quality-Control-Atellica®-IM-SARS-CoV-2-IgG-Positive-Level--Negative-Level-4-X-2-mL11206999

SKU #

#1173394

MPN #

11206999

Brand

Siemens

Stock

In Stock

Quantity

100

Features

CONTROL, ATELLICA COV2G 2X2ML NEG 2X2ML POS (4/KT) D/S

$178.80 USD

Product Specifications Product Usage Additional Information
Print
Attribute Name Attribute Value
McKesson # 1173394
Manufacturer # 11206999
Brand Atellica® IM
Manufacturer Siemens
Application Quality Control
Container Type Vial
For Use With For use with Atellica® IM SARS-CoV-2 IgG (COV2G) Assay on Atellica® IM Analyzer
Levels Positive Level / Negative Level
Product Dating McKesson Acceptable Dating: we will ship >= 30 days
Storage Requirements Requires Refrigeration
Test Name SARS-CoV-2 IgG
Test Type Antibody Test
UNSPSC Code 41116145
Volume 4 X 2 mL
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  • Atellica® IM SARS-CoV-2 IgG (COV2G) 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 of 1988 (CLIA), 42 U.S.C 263a, that meet requirements to perform moderate or high complexity tests
  • 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
  • Atellica IM SARS-CoV-2 IgG (COV2G) assay should not be used to diagnose acute SARS-CoV-2 infection
  • 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 Atellica IM SARS-CoV-2 IgG (COV2G) 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 Atellica IM SARS-CoV-2 IgG (COV2G) assay may occur due to crossreactivity from pre-existing antibodies or other possible causes
  • 2 X 2 mL positive control
  • 2 X 2 mL negative control