LIFESIGN LLC LifeSign Status SARS CoV-2/Flu A&B Test 33225 25 Each-MDL-LSQ33225KT

LIFESIGN LLC LifeSign Status SARS CoV-2/Flu A&B Test

• A rapid immunoassay for the simultaneous direct detection and differential diagnosis of SARS-CoV-2, influenza type A and type B antigen from nasopharyngeal swab specimens
• Visually read in 15 minutes
• Flocked nasopharyngeal swab for superior specimen collection and patient comfort
• This product 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; 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.