Covid Rapid Test QuickVue SARS Antigen Dipstick, Box of 25
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- Rapid detection of SARS-CoV-2 antigens
- Results in 10 minutes for quick assessment
- FDA Emergency Use Authorization (EUA)
- Not FDA cleared or approved
- Designed for authorized laboratory use
- Authorized for emergency use under specified conditions
- Sold as a Box of 25 Kits
Description
FDA Emergency Use Authorization The QuickVue SARS Antigen Test has not been FDA cleared or approved, but has been authorized by the FDA under an Emergency Use Authorization (EUA) for use by authorized laboratories for the detection of proteins from SARS-CoV-2, not for any other viruses or pathogens.
This test 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 authorization is terminated or revoked sooner.
The QuickVue SARS Antigen Test detects SARS-CoV-2 antigens directly from anterior nares swab specimens. The QuickVue SARS Antigen Test provides accurate and reliable results in 10 minutes, allowing for testing of patients suspected of COVID-19/2019-nCoV in near-patient testing environments.
Professional Use Only - Healthcare License Required
| Item # | 203870 |
| MPN | 20387 |
| Manufacturer | Quidel |
| Type | Nasal Swab Sample |
| UOM Packaging | Box of 25 |
| UOM | BX |
| Test Format | Strip |
| Storage Condition | Room Temperature |
| Country of Origin | USA |
| Number of Tests | 25 Tests |
| CLIA | Clia Waived |
| Reading Type | Visual Read |
| Test Type | SARS Antigen |
| Time to Results | 10 minutes |