Product Overview Product feature summary

• This product has not been FDA cleared or approved; but has been authorized by FDA under an EUA

• This product has been authorized only for the detection of proteins from SARS-CoV-2, not for any other viruses or pathogens.

• 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.

Specifications Product specifications and dimensions

• Additional Attributes
  Rx Use
• Brand
  InteliSwab
• Item
  Test Kit
• Item Type
  COVID-19
• Quantity
  24/Box

Catalog Description As seen in our print catalog

This single-use, lateral flow immunoassay with an integrated swab is intended for the qualitative detection of the nucleocapsid protein antigen from SARS-CoV-2 in anterior nasal samples from individuals 18 years or older when the sample is self-collected, or in individuals 2 years or older when the sample is collected by an adult. The test is authorized for individuals who are suspected of having COVID-19 by their health-care provider within 7 days of symptom onset.