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
McKesson #
1180218
Manufacturer #
FRCOAC-012
Brand
NanoEnTek
Manufacturer
NanoEnTek USA Inc
Country of Origin
Unknown
Application
Control Set
Container Type
Vial
For Use With
For Verifying the Proper Function of the FREND System with the FREND COVID-19 Total Ab Cartridge
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