Immunoassay Reagent Frend
COVID-19 Total Ab SARS-CoV-2 Total
For FREND System 20 Tests
NanoEnTek FRCOD-020

Immunoassay Reagent Frend
COVID-19 Total Ab SARS-CoV-2 Total
For FREND System 20 Tests
NanoEnTek FRCOD-020

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 FREND� COVID-19 total Ab is a fluorescence immunoassay (FIA) using the FREND� System intended for the qualitative detection of total antibody to SARS-CoV-2 in human dipotassium EDTA plasma FREND� COVID-19 total Ab is intended for use as an aid in identifying individuals with an adaptive immune response to SARS-CoV-2, indicating recent or prior infection At this time, it is unknown for how long antibodies persist following infection and if the presence of antibodies confers protective immunity; the FREND� COVID-19 total Ab should not be used to diagnose acute SARSCoV-2 infection Laboratories within the United States and its territories are required to report all results to the appropriate public health authorities The sensitivity of FREND� COVID-19 total Ab early after infection is unknown 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 Results can be obtained in less than 3 minutes with only 35 �l of sample volume using the FREND System Kit includes: 20 cartridges, 20 dilution tubes, 40 disposable pipette tips, code chip, and package insert The following materials are NOT provided with the reagent but are required to perform COVID-19 total antibody analysis using the FREND� COVID-19 total Ab on the FREND� System: FREND� System including calibrated pipette and QC Cartridge and QC Code chip manufactured by NanoEntek

Manufacturer # FRCOD-020 Brand Frend� COVID-19 Total Ab Manufacturer NanoEnTek USA Inc Country of Origin Unknown Application Immunoassay Reagent For Use With For FREND System Number of Tests 20 Tests Sample Type Plasma Sample Specialty Immunoassay Test Category Respiratory Test Format Cartridge Test Method Fluorescene Immunoassay (FIA) Test Name SARS-CoV-2 Total Test Type Antibody Test Time to Results 3 Minute Results UNSPSC Code 41116126 Volume 35 �L Sample Volume