- This product has not been FDA cleared or approved; but has been authorized by FDA under an Emergency Use Authorization ( EUA)
- This product has been authorized only for the detection of proteins from SARS- CoV-2, not for any other viruses or pathogens;
- The emergency use of this product is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Federal Food, Drug and Cosmetic Act, 21 U.S.C. § 360bbb-3(b)(1), unless the declaration is terminated or authorization is revoked sooner.
If you’re currently experiencing COVID-19 symptoms, please contact your primary care physician (PCP) for immediate guidance.
MediConcepts® COVID-19 Antigen Rapid Test may take several days to ship. This is not a PCR test and not valid for travel. The Antigen Rapid Test requires test kits be stored at temperatures between 36o and 86oF (2o – 30oC). Any extended exposure of the test kit to temperatures beyond this range may affect quality of test results.
