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BD Veritor™ SARS-CoV-2 Control Swabs
10 SARS-CoV-2 positive and 10 SARS-CoV-2 negative quality control swabs
Supplier: BD Veritor™ 256087
Description
- To be used with BD Veritor™ System
- For Rapid Detection of SARS-CoV-2 (256082)
Specifications
| SARS-CoV-2 | |
| BD Veritor System for Rapid Detection of SARS-CoV-2 (256082) | |
| Control Swab |
| 10 Paired Positive/Negative Control Swabs | |
| Nasal 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.