Home / Clinical Laboratory / Clinical Analyzer Calibrators and Reagents / Reagents / Reagent Kit / Reagent Kit Access® Antibody Test SARS-CoV-2 IgM For use with Access Family of Immunoassay Systems 200 TestsC58957
Picture of Reagent Kit Access® Antibody Test SARS-CoV-2 IgM For use with Access Family of Immunoassay Systems 200 TestsC58957

Reagent Kit Access® Antibody Test SARS-CoV-2 IgM For use with Access Family of Immunoassay Systems 200 TestsC58957

Reagent-Kit-Access®-Antibody-Test-SARS-CoV-2-IgM-For-use-with-Access-Family-of-Immunoassay-Systems-200-TestsC58957

SKU #

#1172371

MPN #

C58957

Brand

Beckman Coulter

Stock

In Stock

Quantity

100

Features

REAGENT KIT, ACCESS SARS-COV-2IGM (200TST/KT) D/S

$1,299.25 USD

Product Specifications Product Usage Additional Information
Print
Attribute Name Attribute Value
McKesson # 1172371
Manufacturer # C58957
Brand Access®
Manufacturer Beckman Coulter
Application Reagent Kit
Container Type Well
For Use With For use with Access Family of Immunoassay Systems
Form Liquid
Number of Tests 200 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
Time To Results 37 Minute Results
Type Two-step Immunocapture Immunoassay
UNSPSC Code 41116144
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  • The Access SARS-CoV-2 IgM Assay is only for use under the FDA'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
  • Access SARS%XE2%X80?CoV%XE2%X80?2 IgM is a paramagnetic particle, chemiluminescent immunoassay intended for the qualitative detection of IgM antibodies to SARS%XE2%X80?CoV%XE2%X80?2 in human serum, serum separator tubes and plasma (lithium heparin, dipotassium EDTA, tripotassium EDTA, sodium citrate)
  • Access SARS%XE2%X80?CoV%XE2%X80?2 IgM is intended for use as an aid in identifying individuals with an adaptive immune response to SARS%XE2%X80?CoV%XE2%X80?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 results to the appropriate public health authorities
  • The sensitivity of the Access SARS-CoV-2 IgM assay early after infection is unknown; negative results do not preclude acute SARS-CoV-2 infection
  • False positive results for the Access SARS%XE2%X80?CoV%XE2%X80?2 IgM assay may occur due to cross%XE2%X80?reactivity from pre%XE2%X80?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 assay
  • Time-to-first result (approx.): 37 minutes
  • Sample volume: 10uL