Antibody Test Control Set NanoEnTek COVID-19 Total Ab Positive Level / Negative Level

$207.71
In stock
Product Code :
MPSMK-1180218
More Information
MPN 1180218
Brand McKesson
Packaging KT/1

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Features
  • The FREND COVID-19 total Ab assay is only for use under the Food and Drug Administrations 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
  • The COVID-19 total Ab Control LQ should only be used with the FREND System
  • 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 SARS-CoV-2 infection; if acute infection is suspected, direct testing for SARS-CoV2 is necessary
  • False positive results for FREND COVID-19 total Ab may occur due to cross-reactivity from preexisting antibodies or other possible causes
  • Due to the risk of false positive results, confirmation of positive results should be considered using second, different total antibody assay
  • COVID-19 total Ab Control LQ is not intended for use as a standard
  • Includes: 6 Vials of Negative control in inactivated human serum
  • Includes: 6 Vials of Positive control (negative control spiked with COVID19 antibodies)

Product Specifications

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