BD Veritor™ Combo Pack: 2 SARS-CoV-2 Kits and 1 Analyzer

Description

Promotional kit for rapid detection of SARS-CoV-2 (COVID-19) in 15 minutes

• Get rapid, reliable SARS-CoV-2 results in just 15 minutes
• Dual anterior nares sample collection
• Clear, digitally displayed results that detect positives not recognized by the unaided eye.
• Virtual SKU contains QTY 2 of BD Veritor™ System for Rapid Detection of SARS-CoV-2 (256082) and QTY 1 of BD Veritor™ Plus Analyzer (256066)
• Contains 60 tests and 1 instrument

Specifications

• Certifications/Compliance: Certificate of Conformance
• Content And Storage: 2°C to 30°C
• Control Sets: SARS+, SARS- included
• CPT Code: 87426
• CE Marker: No
• Clia Complexity: Waived
• Detectable Analytes: SARS-CoV-2
• DoA Calibrators: No
• Sample Type: Dual Anterior Nares
• Sensitivity: 84%
• Type: Rapid Antigen
• For Use With (Application): Laterial Flow Immunoassay
• For Use With (Equipment): BD Veritor Plus Analyzer (256066) Included in This Promotional Kit
• Quantity: 60 Tests, 1 Analyzer
• Specificity: 1
• Test Time: 15 min.
• Form: Liquid

*The BD Veritor™ Plus System for Rapid Detection of SARS-CoV-2 is intended for the qualitative detection of SARS-CoV-2 nucleocapsid antigens in direct anterior nasal swabs from individuals who are either suspected of COVID-19 by their health care provider within the first five days of the onset of symptoms, or from individuals without symptoms or other epidemiological reasons to suspect COVID-19 when tested twice over two or three days with at least 24 hours and no more than 48 hours between tests.

• 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.
• 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.