Coronavirus antigen detection test system - Product Usage: intended for the qualitative detection of the nucleocapsid protein antigen to SARS-CoV-2 directly from nasal swab samples collected from individuals suspected of COVID-19 by their healthcare provider within the first twelve days of symptom onset.
Two lots of test strips failed QC testing using blank buffer due to false positives.
US nationwide distribution.
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1312-2021