Abbott Point Of Care POC BINAXNOW® 195-000 BinaxNOW™ COVID-19 Ag Card Kit, Professional Use, CLIA Waived, 40 tests/kit (Short-Dated; Non-Returnable) (Clia Waive Certificates Required for Drop Ship Orders) (Continental US+HI Only) , kit

Abbott Point Of Care POC BINAXNOW® 195-000 BinaxNOW™ COVID-19 Ag Card Kit, Professional Use, CLIA Waived, 40 tests/kit (Non-returnable; Non-refundable) (Clia Waive Certificates Required for Drop Ship Orders) (Continental US+HI Only)

Features:

• BinaxNOW COVID-19 Ag Test is a lateral flow immunoassay intended for the qualitative detection of nucleocapsid protein antigen from SARS-CoV-2 in nasal swabs within the first 7 days of symptom onset
• Does not differentiate between SARS-CoV and SARS-CoV-2
• For use at the point of care in settings operating under CLIA Certificate of Waiver, Certificate of Compliance or Certificate of Accreditation
• Results visually read at 15 minutes
• Emergency Use Authorization (EUA) acknowledgement form must be signed and submitted to your Medline sales rep
• 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, not for any other viruses or pathogens; and,
• 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. A,§ 360bbb-3(b)(1), unless the declaration is terminated or authorization is revoked sooner.