OraSure Technologies InteliSwab™ COVID-19 Rapid Test Pro Visual Reference Panel

Description

Intended to assist new operators in becoming proficient at reading specimens with antigen levels near limit of detection of the device

• Comprised of InteliSwab™ COVID-19 Rapid Test Pro devices that have been designed to represent reading intensities of limit of detection, low positive and negative test results
• Kit contains:
  • Instructions for use (IFU)
  • Foil pouch with:
    • One COVID-19 limit of detection device
    • One COVID-19 low positive device
    • One COVID-19 negative device

Specifications

• Certifications/Compliance: FDA EUA
• CE Marker: No
• Clia Complexity: Waived
• Type: Visual Reference Panel
• For Use With (Application): Practice reading specimens with antigen levels near the limit of detection
• For Use With (Equipment): InteliSwab™ COVID-19 Rapid Test Pro
• Includes: Instructions for use, COVID-19 limit of detection device, COVID-19 low positive device, COVID-19 negative device
• Packaging Type: Kit

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.