Home / Clinical Laboratory / Controls / Control Kit / Antibody Test Control Kit NanoEntek COVID-19 Total Ab Positive Level / Negative LevelFRCOAC-012
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Antibody Test Control Kit NanoEntek COVID-19 Total Ab Positive Level / Negative LevelFRCOAC-012

Antibody-Test-Control-Kit-NanoEntek-COVID-19-Total-Ab-Positive-Level--Negative-LevelFRCOAC-012

SKU #

#1180218

MPN #

FRCOAC-012

Brand

NanoEnTek USA Inc

Stock

In Stock

Quantity

100

Features

CONTROL, FREND COVID-19 TOTAL ANTIBODY 6POS/6NEG (1/KT) D/S

$119.20 USD

Product Specifications Product Usage Additional Information
Print
Attribute Name Attribute Value
McKesson # 1180218
Manufacturer # FRCOAC-012
Brand NanoEnTek
Manufacturer NanoEnTek USA Inc
Application Control Kit
Container Type Vial
For Use With For Verifying the Proper Function of the FREND System with the FREND COVID-19 Total Ab Cartridge
Form Liquid
Levels Positive Level / Negative Level
Test Name COVID-19 Total Ab
Test Type Antibody Test
UNSPSC Code 41116128
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  • The FREND™ COVID-19 total Ab assay is only for use under the Food and Drug Administration’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
  • 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)