BD Veritor™ SARS-CoV-2 Control Swabs

Description

10 SARS-CoV-2 positive and 10 SARS-CoV-2 negative quality control swabs

• To be used with BD Veritor™ System
• For Rapid Detection of SARS-CoV-2 (256082)

Specifications

• Detectable Analytes: SARS-CoV-2
• Format: 10 Paired Positive/Negative Control Swabs
• For Use With (Equipment): BD Veritor System for Rapid Detection of SARS-CoV-2 (256082)
• Sample Type: Nasal Swab
• Type: Control Swab

*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.