Home / Clinical Laboratory / Clinical Analyzer Calibrators and Reagents / Reagents / Reagent Kit / Reagent Kit AdviseDx Antibody Test SARS-CoV-2 IgM For use with ARCHITECT i System 100 Tests 24 mL06R8720
Picture of Reagent Kit AdviseDx Antibody Test SARS-CoV-2 IgM For use with ARCHITECT i System 100 Tests 24 mL06R8720

Reagent Kit AdviseDx Antibody Test SARS-CoV-2 IgM For use with ARCHITECT i System 100 Tests 24 mL06R8720

Reagent-Kit-AdviseDx-Antibody-Test-SARS-CoV-2-IgM-For-use-with-ARCHITECT-i-System-100-Tests-24-mL06R8720

SKU #

#1179192

MPN #

06R8720

Brand

Abbott

Stock

In Stock

Quantity

100

Features

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

$697.31 USD

Product Specifications Product Usage Additional Information
Print
Attribute Name Attribute Value
McKesson # 1179192
Manufacturer # 06R8720
Brand AdviseDx
Manufacturer Abbott
Application Reagent Kit
Container Type Bottle
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 IgM
Test Type Antibody Test
Type Chemiluminescent Microparticle Immunoassay (CMIA)
UNSPSC Code 41116010
Volume 24 mL
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  • The AdviseDx SARS-CoV-2 IgM Assay is for use under an FDA EUA only: 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 (CLIA) of 1988, 42 U.S.C 263a, that meet requirements to perform moderate or high complexity tests
  • The AdviseDx SARS-CoV-2 IgM assay is a chemiluminescent microparticle immunoassay (CMIA) intended for the qualitative detection of IgM antibodies to SARS-CoV-2 in human serum, serum separator tube, and plasma (dipotassium EDTA, tripotassium EDTA, lithium heparin, lithium heparin separator tube, sodium heparin)
  • At this time, it is unknown for how long antibodies persist following infection and if the presence of antibodies confers protective immunity; AdviseDx SARSCoV-2 IgM 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 results to the appropriate public health authorities
  • Negative results do not preclude acute SARSCoV-2 infection; if acute infection is suspected, direct testing for SARS-CoV-2 is necessary
  • False positive results for the AdviseDx SARS-CoV-2 IgM assay may occur due to cross-reactivity from pre-existing antibodies or other possible causes
  • Due to the risk of false positive results, confirmation of positive results should be considered using a second, different IgM assay
  • This test has been authorized only for the presence of IgM antibodies against SARS-CoV-2, not for any other viruses or pathogen
  • This test is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked soone