Home / Clinical Laboratory / Controls / Quality Control / Antibody Test Quality Control Access® SARS-CoV-2 IgM Level 1, 2 3 X 4 mL per LevelC58959
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Antibody Test Quality Control Access® SARS-CoV-2 IgM Level 1, 2 3 X 4 mL per LevelC58959

Antibody-Test-Quality-Control-Access®-SARS-CoV-2-IgM-Level-1,-2-3-X-4-mL-per-LevelC58959

SKU #

#1172373

MPN #

C58959

Brand

Beckman Coulter

Stock

In Stock

Quantity

100

Features

CONTROL, ACCESS SARS-COV-2 IGMQC 4ML (1/BX) D/S

$381.43 USD

Product Specifications Product Usage Additional Information
Print
Attribute Name Attribute Value
McKesson # 1172373
Manufacturer # C58959
Brand Access®
Manufacturer Beckman Coulter
Application Quality Control
Container Type Vial
For Use With For Monitoring System Performance of the Access SARS-CoV-2 IgM Assay on the Access Family of Immunoassay Systems only
Form Liquid
Levels Level 1, 2
Product Dating McKesson Acceptable Dating: we will ship >= 30 days
Storage Requirements Requires Refrigeration
Test Name SARS-CoV-2 IgM
Test Type Antibody Test
UNSPSC Code 41116145
Volume 3 X 4 mL per Level
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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
  • QC1: Negative: TRIS buffer, defibrinated human plasma negative for anti-SARS-CoV-2, surfactant, protein (bovine), < 0.1% sodium azide and 0.5% ProClin* 300
  • QC2: Positive: TRIS buffer, defibrinated human plasma, human IgM conjugated to anti-SARS-CoV-2 antibodies, surfactant, protein (bovine), < 0.1% sodium azide and 0.5% ProClin 300
  • This product 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 sooner