Product Overview Product feature summary

• This product has not been FDA cleared or approved, but has been authorized by FDA under an EUA for use by authorized laboratories.

• Authorized laboratories are those that are certified under CLIA that meet the requirements to perform moderate, high or waived complexity tests. The test is authorized for use in point of care settings operating under a CLIA Certificate of Waiver, Certificate of Compliance or Certificate of Accreditation.

• 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. LI>

Specifications Product specifications and dimensions

• Brand
  InteliSwab
• Item
  Control Kit
• Item Type
  COVID-19
• Level
  Positive/ Negative
• Quantity
  2/Box