Ellume COVID Test Kit, at Home COVID-19 Home Test Kit, Rapid Antigen Self Test, Results in 15 Minutes to Your Free Mobile app, FDA Emergency Use Authorization, 1 Pack

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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; and, 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. FALSE RESULTS: We’re not perfect, but we’re trying to be. Thanks to our test’s unique features, including our internal sample quality control system, the Ellume COVID-19 Home test is one of the most accurate OTC home antigen tests available. Unfortunately, no test is perfect and false positive and false negative results are possible with all COVID tests. Please refer to our FAQ to learn more about false results or to review our clinical trial data. If you have received a false result, please call our Customer Support.
Product Dimensions‏:‎5.9 x 3.8 x 2.2 inches; 3.07 Ounces
Batteries‏:‎1 Lithium Metal batteries required. (included)
Date First Available‏:‎June 3, 2021
Manufacturer‏:‎Ellume
ASIN‏:‎B096L27S73

RESULTS IN ONE TEST, IN 15 MINUTES. THE ONLY OTC ANTIGEN HOME TEST THAT GIVES YOU HIGHLY ACCURATE RESULTS IN A SINGLE TEST. Other home antigen tests require a 2nd test 2 – 3 days after the first. Test includes Analyzer, Nasal Swab with Child Adapter, Dropper, Processing Fluid.
HIGHLY ACCURATE RESULTS. The Ellume COVID-19 Home Test is highly accurate. During a 2020 clinical study the test correctly identified people with symptoms in 96% of positive samples and 100% of negative samples. In people without symptoms 91% of positive samples & 96% of negative samples.
RESULTS YOU CAN TRUST. This test utilizes sample quality control technology, which other OTC antigen home tests do not have. This quality control detects if your swab sample is sufficient to generate a reliable result. A false negative result increases the risk of spreading COVID-19.
TEST FOR CURRENT AND NEW COVID VARIANTS. The Ellume COVID-19 Home Test targets a protein deep in the virus (the nucleocapsid protein), which remains largely unchanged in the latest SARS-CoV-2 virus variants. Ellume has an ongoing program to test new variants as they appear.
AVAILABLE FOR TRAVEL. The test is authorized for domestic travel in the U.S. and is available for international travel with an Azova video observation session, sold separately via Azova. Restrictions apply. Check with your travel partner and destination before purchase. Need Support, contact Ellume.

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