Learn More
OraSure Technologies InteliSwab™ COVID-19 Rapid Test Pro Kit Controls
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
Specifications
| Content And Storage | 36°F to 46°F |
| Detectable Analytes | SARS-CoV-2 Nucleocapsid Protein Antigen |
| For Use With (Equipment) | InteliSwab™ COVID-19 Rapid Test Pro |
| Type | InteliSwab™ Kit Controls |
| Includes | Instructions for use, Specimen collection loops, COVID-19 positive control, COVID-19 negative control |
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.
Your input is important to us. Please complete this form to provide feedback related to the content on this product.