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GenBody Rapid Antigen Test Is Added to Growing Lineup of COVID-19 Diagnostic Testing

by Luke Kervin,
Co-Founder of PatientPop

Authority Magazine | Feb, 10

Recent Articles

GenBody America’s Diagnostic Kit Manufacturing Plant Opens and Begins Production in Southern California

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GenBody America’s COVID-19 Antigen Tests Now Authorized for Serial Testing for Asymptomatic Individuals

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3420 De Forest Cir
Jurupa Valley, CA 91752

949-561-0664
ts@genbodyamerica.com
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The GenBody COVID-19 Ag test has not been FDA cleared or approved, but has been authorized by FDA under an EUA for use by authorized laboratories. The product has been authorized only for the detection of proteins 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.

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