Healgen Scientific is thrilled to share that the Healgen COVID-19/Flu A&B Rapid Antigen Test Cassette (Swab) Test has received Emergency Use Authorization! This test is for prescription use only. We are committed to supporting global efforts to prevent the spread of these illnesses, and we are one step closer to ensuring a safer and healthier world for all of us. For more information on our tests, you can visit https://www.healgen.com/index.html or send an email to inquiry@healgen.com
The Healgen COVID-19/Flu A&B Rapid Antigen Test Cassette (Swab) Test has not been FDA cleared or approved, but has been authorized by FDA under an EUA for use by authorized laboratories.
This product has been authorized only for the detection of proteins from SARS-CoV-2, influenza A and influenza B, 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.
