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OraSure Technologies InteliSwab™ COVID-19 Rapid Test Pro Kit Controls
External quality control reagents to monitor the performance of InteliSwab™ COVID-19 rapid test pro with direct anterior nasal samples
Supplier: OraSure Technologies 10010613
Description
- For use only with InteliSwab™ COVID-19 Rapid Test Pro
- Kit control box contains:
- Instructions for use (IFU)
- Specimen collection loops
- Two vials:
- One COVID-19 positive control
- One COVID-19 negative control
Specifications
| 36°F to 46°F | |
| InteliSwab™ COVID-19 Rapid Test Pro | |
| Instructions for use, Specimen collection loops, COVID-19 positive control, COVID-19 negative control |
| SARS-CoV-2 Nucleocapsid protein antigen | |
| InteliSwab™ Kit Controls |
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Product Title
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. 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.
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