Product Overview Product feature summary

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

• Authorized laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), that meet the requirements to perform high, moderate or waived complexity tests. This test is authorized for use at the Point of Care, i.e.,in patient care settings operating under a CLIA Certificate of Waiver, Certificate of Compliance or Certificate of Accreditation.

• This product has been authorized only for detecting the presence of total antibodies to 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

• Brand
  CovAb
• Item
  Control
• Item Type
  SARS-CoV-2
• Level
  Positive/ Negative
• Quantity
  1/Box

Catalog Description As seen in our print catalog

The test is the only 15-minute, rapid-result oral swab test kit for qualitative detection of total COVID-19 antibodies (including IgG, IgA, and IgM). The test is intended for use as an aid in identifying individuals with an adaptive immune response to SARS-CoV-2, indicating recent or prior infection. Samples should only be taken from individuals that are 15 days or more post symptom onset. Unlike other antibody tests that require a blood draw, it is administered with a simple mouth swab, making it easy and painless for patients of all ages. Stores at room temperature and is manufactured in the USA. 97.6% sensitivity, 98.8% specificity*. CLIA waived.