FaStep Antigen Pen Home Test, COVID-19
2 tests
On This Page
Directions
1. Swab both nostrils. 2. Orange band covered. 3. Results window. For symbol glossary, refer to instructions use. Store between 36-86 degrees F (2-30 degrees C) until use.
Product Details
For ages 2 and up. Box Contents: 2x bases; 2x test pens; 1x instruction for use. Self-test. Quick results in 15 minutes. Easy to use. For use under the FDA emergency. Use authorization (EUA) only. For emergency use authorization (EUA) only. For in vitro diagnostic use. In the USA, 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. Determining a negative result requires multiple tests. You may need to purchase additional tests to perform serial (repeat) testing. This test is more likely to give you a false negative result when you have COVID-19 than a lab-based molecular test. Items necessary to use the test but not in the provided test kit. https://www.fda.gov/covid-tests. Download instructions for use. For information about current dates for at-home OTC COVID-19 diagnostic tests, visit https://www.fda.gov/covid-tests. [email protected]. 1-800-281-9867. Made in China.Nutrition Facts
Manufacturer
Azure Biotech, Inc.
10400 Main Street Houston, TX 77025 United States
UPC
00810022630426