Learn more about the Detect Covid-19 Test™.
Product Information Sheets:
Instructions for Use (Home User)
Instructions for Use for Healthcare Providers
Fact Sheet for Healthcare Professionals
Fact Sheet for Individuals
Hub User Manual
Contact firstname.lastname@example.org in order to request a paper copy of any of the product information sheets.
This product has not been FDA cleared or approved, but has been authorized by FDA under an EUA;
This product has been authorized only for the detection of nucleic acid from SARS- CoV-2, not for any other viruses or pathogens; and,
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.