Respiratory - Respiratory
Coronavirus (COVID-19)
statID PRO
StatID PRO™ COVID-19/Flu A&B
The StatID PRO COVID-19/Flu A&B is a lateral flow immunochromatographic assay intended for the qualitative detection and differentiation of influenza A, and influenza B nucleoprotein antigens and SARS-CoV-2 nucleocapsid antigen directly in anterior nasal swab samples from individuals with signs and symptoms of respiratory tract infection.
Standard™ Q
COVID-19 Ag Test 2.0
Standard™ Q COVID-19 Ag Test 2.0
Standard™ Q COVID-19 Ag Test 2.0 is a rapid test for the qualitative detection of nucleocapsid antigen from SARS-CoV-2 in nasal swabs from individuals suspected of being infected with SARS-CoV-2 by their healthcare provider within the first 6 days of onset of symptoms or from individuals without symptoms or for serial screening. Emergency Use Authorization (EUA) approved.
revogene
Premier® SARS-CoV-2
A real-time Reverse Transcription Polymerase Chain Reaction (rRT-PCR) qualitative test run on the Revogene® instrument for the detection of SARS-CoV-2 nucleic acid from nasopharyngeal, oropharyngeal, anterior nasal, and mid-turbinate nasal swab specimens.
Revogene SARS-CoV-2 assay – 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. 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 Cosmetic Act, 21 U.S.C. § 360bbb-3 (b)(1), unless the declaration is terminated, or authorization is revoked sooner.