Test for Active/Current Infection with this Rapid Antigen Test.
- ** 20 TESTS PER BOX **
- For Anterior (shallow) and Nasopharyngeal (deep) applications.
- FDA Authorized (EUA).
- Authorized for use in Point-of-Care (patient) settings under CLIA Waiver/Certificate/Accreditation.
- For medical professional use only. Not for home use.
- 93.75% PPA & 99.32% NPA (with nasopharyngeal swab)
CLIA # required at checkout.
** How should Rapid Antigen Tests be used? Click here
** Shipping UPS Ground only (no expedited requests at this time)
** All sales are final. No Cancelations/Refunds/Returns **
FACT SHEET FOR PATIENTS
FACT SHEET FOR HEALTHCARE PROVIDERS
IFU (INSTRUCTIONS FOR USE) (PACKAGE INSERT)
FDA EMERGENCY USE AUTHORIZATION (EUA) LIST
SUMMARY & EXPLANATION
This test is for detection of SARS-CoV-2 nucleocapsid protein antigen. Antigen is generally detectable in upper respiratory specimens during the acute phase of infection. Rapid diagnosis of SARS-CoV-2 infection will help healthcare professionals to treat patients and control the disease more efficiently and effectively.
20 test devices
20 assay buffer
20 extraction vials and caps
20 specimen collection swabs
1 positive and 1 negative control swabs
1 instructions for use
- This test has not been FDA cleared or approved;
- This test has been authorized by FDA under an EUA for use by authorized laboratories;
- This test has been authorized only for the detection of proteins from SARSCoV-2, not for any other viruses or pathogens; and
This test 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 authorization is terminated or revoked sooner.