Respiratory - Respiratory
GenBody COVID-19 Ag
intended for the qualitative detection of nucleocapsid antigen
from SARS-CoV-2 in nasal swab specimens from individuals who are suspected of being infected with SARS-CoV-2 by their healthcare provider within the first 6 days of onset of symptoms.
Emergency Use Authorization (EUA) approved.
In the USA, this product has not been FDA cleared or approved, but has been authorized by FDA under an EUA for use by authorized laboratories certified under the CLIA, 42 U.S.C. §263a, that meet requirements to perform moderate, high or waived complexity tests. This test is authorized for use at the Point of Care (POC), i.e., in patient care settings operating under a CLIA Certificate of Waiver, Certificate of Compliance, or Certificate of Accreditation. This product has been authorized only for the detection of proteins from SARS-CoV-2, not for any other viruses or pathogens. In the USA, 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 the virus that causes 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