Home / Clinical Laboratory / Controls / Control Kit / Antibody Test Control Kit Atellica® IM SARS-CoV-2 Total Positive Level / Negative Level 2 X 2 X 7 mL11206712
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Antibody Test Control Kit Atellica® IM SARS-CoV-2 Total Positive Level / Negative Level 2 X 2 X 7 mL11206712

Antibody-Test-Control-Kit-Atellica®-IM-SARS-CoV-2-Total-Positive-Level--Negative-Level-2-X-2-X-7-mL11206712

SKU #

#1167947

MPN #

11206712

Brand

Siemens

Stock

In Stock

Quantity

100

Features

CONTROL, ATELLICA IM SARS-COV-2 TOTAL ANTIBODY 2X2X7ML D/S

$178.80 USD

Product Specifications Product Usage Additional Information
Print
Attribute Name Attribute Value
McKesson # 1167947
Manufacturer # 11206712
Brand Atellica® IM
Manufacturer Siemens
Application Control Kit
Container Type Vial
For Use With For use with Atellica® IM SARS-CoV-2 Total (COV2T) Assay on Atellica® IM Analyzer
Form Liquid
Levels Positive Level / Negative Level
Product Dating McKesson Acceptable Dating: we will ship >= 90 days
Storage Requirements Requires Refrigeration
Test Name SARS-CoV-2 Total
Test Type Antibody Test
UNSPSC Code 41116145
Volume 2 X 2 X 7 mL
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  • Atellica® IM SARS-CoV-2 Total (COV2T) 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
  • Intended for qualitative detection of total antibodies (including IgG and IgM) to SARS-CoV-2 in human serum and plasma (potassium EDTA and lithium heparin) using the Atellica® IM Analyzer
  • 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
  • Atellica IM SARS-CoV-2 Total (COV2T) assay is intended as an aid in identifying patients 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
  • The sensitivity of the Atellica IM SARS-CoV-2 Total (COV2T) 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 Total (COV2T) assay may occur due to cross-reactivity from pre-existing antibodies or other possible causes
  • 2 x 2.0 mL negative quality control, level 1
  • 2 x 2.0 mL positive quality control, level 2