SelfCheck® Nasal Swabbing Kit
Cleveland Clinic’s SelfCheck® Nasal Swabbing Kit is designed to allow you to conveniently collect a nasal sample to be tested for the novel 2019 coronavirus (COVID-19).
Please note: At this time, the SelfCheck® Nasal Swabbing Kit is only available for patients in Northeast Ohio who have a provider's order. Check with your provider for more information.
Additional Information for Patients and Medical Providers
- This product has not been FDA cleared or approved, but has been authorized for emergency use by FDA under an EUA for use by authorized laboratories.
- When used with SelfCheck cobas SARS-CoV-2 + Flu Assay: This product has been authorized only for the detection of nucleic acid from SARS-CoV-2, influenza A and/or influenza B, not for any other viruses or pathogens.
- When used with SelfCheck cobas SARS-CoV-2 Assay: This product has been authorized only for the detection of nucleic acid 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 Cosmetics Act, 21 U.S.C. § 360bbb-3(b)(1), unless the declaration is terminated or authorization is revoked sooner. Updated 01/25/21.