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