Accessbio CareStart COVID-19 Antigen Test, OTC Use, Non-Returnable, Optum - RCPM-00279 - 2 Each

Accessbio CareStart COVID-19 Antigen Test, OTC Use, Non-Returnable, Optum

Add the Accessbio CareStart COVID-19 Antigen Test, OTC Use, Non-Returnable, Optum to standing supply orders to keep departments stocked. Lateral flow assay for the detection of SARS-CoV-2 nucleocapsid protein antigen. Specifications include latex-free materials.

Key Features

• Nasopharyngeal swab specimen collection.
• Provides rapid results in 10 minutes for point-of-care convenience; point-of-care test only.
• Identifies acute infection in symptomatic patients with 88.4% sensitivity and 100% specificity.
• FDA EUA test; designated as a CLIA waived tests.
• This product has not been FDA cleared or approved; but has been authorized by FDA under an EUA.
• This 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.

Specifications