Home / Clinical Laboratory / Clinical Analyzer Calibrators and Reagents / Calibrators / Calibrator Kit / Calibrator Kit Alinity i SARS-CoV-2 IgG For the Calibration of the Alinity i System when used for the Qualitative Detection of IgG Antibodies to SARS-CoV-2 in Human Serum and Plasma06R9001
Picture of Calibrator Kit Alinity i SARS-CoV-2 IgG For the Calibration of the Alinity i System when used for the Qualitative Detection of IgG Antibodies to SARS-CoV-2 in Human Serum and Plasma06R9001

Calibrator Kit Alinity i SARS-CoV-2 IgG For the Calibration of the Alinity i System when used for the Qualitative Detection of IgG Antibodies to SARS-CoV-2 in Human Serum and Plasma06R9001

Calibrator-Kit-Alinity-i-SARS-CoV-2-IgG-For-the-Calibration-of-the-Alinity-i-System-when-used-for-the-Qualitative-Detection-of-IgG-Antibodies-to-SARS-CoV-2-in-Human-Serum-and-Plasma06R9001

SKU #

#1166394

MPN #

06R9001

Brand

Abbott

Stock

In Stock

Quantity

100

Features

CALIBRATOR, ALINITY I SARS-COVIGG (1/EA) D/S

$106.20 USD

Product Specifications Product Usage Additional Information
Print
Attribute Name Attribute Value
McKesson # 1166394
Manufacturer # 06R9001
Brand Alinity I
Manufacturer Abbott
Application Calibrator Kit
For Use With For the Calibration of the Alinity i System when used for the Qualitative Detection of IgG Antibodies to SARS-CoV-2 in Human Serum and Plasma
Product Dating McKesson Acceptable Dating: we will ship >= 90 days
Storage Requirements Requires Refrigeration
Test Name SARS-CoV-2 IgG
Test Type Antibody Test
UNSPSC Code 41116145
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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
  • The SARS-CoV-2 IgG Calibrator Kit is for the calibration of the Alinity i system when used for the qualitative detection of IgG antibodies to SARS-CoV-2 in human serum, serum separator tube and plasma (ACD, CPD, CPDA-1, dipotassium EDTA, tripotassium EDTA, lithium heparin, lithium heparin separator tube, sodium citrate, sodium heparin)
  • Calibrator contains inactivated, cell-free, human blood-derived material, reactive for anti-SARS-CoV-2 IgG