[Antigen Test] Advin COVID-19 Antigen Test @Home (288/case)

Test for Active/Current Infection with rapid Antigen Tests.

• ** 288 TESTS PER CASE (MINIMUM ORDER QUANTITY) **
  
• Detects current circulating variants/strains (BA.2.86 "ERIS" or "Pirola", XBB.1.5, etc.) 
• 10 minute results
• FDA Authorized (EUA)
  
• For Home Use / Over-the-counter (OTC)
  
• Analytic performance data here
  

HOME TEST IFU (INSTRUCTIONS)
FACT SHEET FOR HEALTHCARE PROVIDERS
IFU (INSTRUCTIONS FOR USE) (PACKAGE INSERT)
FDA EMERGENCY USE AUTHORIZATION (EUA) LETTER

 

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.

 

MATERIALS SUPPLIED

288 test cassettes
288 extraction  buffer tubes
288 disposal bags
288 sterile nasal swabs
Quick reference guide

 

The Advin COVID-19 Antigen Test @Home is for use under Emergency Use Authorization (EUA) only. 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. 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.