Home / Clinical Laboratory / Controls / Control Kit / Antibody Test Control Kit AdviseDx SARS-CoV-2 IgM Positive Level / Negative Level 2 X 4.0 mL06R8710
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Antibody Test Control Kit AdviseDx SARS-CoV-2 IgM Positive Level / Negative Level 2 X 4.0 mL06R8710

Antibody-Test-Control-Kit-AdviseDx-SARS-CoV-2-IgM-Positive-Level--Negative-Level-2-X-4-0-mL06R8710

SKU #

#1179191

MPN #

06R8710

Brand

Abbott

Stock

In Stock

Quantity

100

Features

CONTROL, SARS-COV-2 IGM ARCH (1/BX) D/S

$160.92 USD

Product Specifications Product Usage Additional Information
Print
Attribute Name Attribute Value
McKesson # 1179191
Manufacturer # 06R8710
Brand AdviseDx
Manufacturer Abbott
Application Control Kit
Container Type Vial
For Use With For the Estimation of Test Precision and the Detection of Systematic Analytical Deviations of the ARCHITECT i System when used for the Qualitative Detection of IgM Antibodies to SARS-CoV-2
Levels Positive Level / Negative Level
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 41116128
Volume 2 X 4.0 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
  • AdviseDx SARS-CoV-2 IgM Control Kit is for the estimation of test precision and the detection of systematic analytical deviations of the ARCHITECT i System when used 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
  • Negative control contains human plasma
  • Positive control contains inactivated, cell-free, human blood-derived material, reactive for anti-SARS-CoV-2 IgM
  • This product has been authorized only for the presence of IgM antibodies against SARSCoV-2, not for any other viruses or pathogens
  • This product is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostic tests for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner