When the seller claims that they can import iHealth tests directly from China.When the seller offers the pricing below market rates.Please be cautious of the following situations: In conjunction with vaccination and other measures, self-testing can help reduce the chance. MaximBio ClearDetect Covid-19 Test Kit At Home Rapid Antigen Self Testing FDA EUA Authorized, Easy Nasal Swab, Fast Results in 15 Minutes, 2 Tests Pack. COVID-19 Rapid Antigen Over-The-Counter Test Kits Information. Also, our manufacturer will NOT supply to any other organizations in the U.S. On/Go One Rapid COVID-19 Self-Test Kit with Test-to-Treat App, 1 Pack, 1 Test Total, 15-Minute Results, FDA EUA Authorized, Easy to Use at Home. Australians will be able to buy rapid antigen tests from November 1 that will allow them to test at home whether they have COVID-19. that may legally sell and distribute the Kit under FDA EUA. We, iHealth Labs Inc, hereby clarify that we and our authorized distributors are the only organizations in the U.S. It has come to our attention that there is some false information regarding the price of iHealth Covid-19 Antigen Rapid Test (the "Kit") in the U.S. If you have ordered home delivery of the test kit and expect temperatures in your area to be outside of this range at time of delivery, it is recommended that you arrange for someone to be home at or near time of delivery to receive the test kit. Any extended exposure of the test kit to temperatures beyond this range may affect quality of test results. Buy now: 75 for starter kit (1 test and 1 hub), 49 for each additional test, and 20 for a video observation session voucher to certify results for travel,. The manufacturer of the iHealth® COVID-19 Antigen Rapid Test requires test kits be stored at temperatures between 36 o and 86 oF (2 o - 30 oC). As more parts of the world reopen and we co-exist with COVID-19, fast and reliable rapid tests will remain a critical tool. This is not a PCR test and not valid for travel. IHealth® COVID-19 Antigen Rapid Test may take several days to ship. Schools are distributing free, take-home COVID-19 rapid test kits to any students or staff who exhibit COVID-like symptoms or have been in a classroom where. § 360bbb-3(b)(1), unless the declaration is terminated or authorization is revoked sooner.ĭisclaimer: If you’re currently experiencing COVID-19 symptoms, please contact your primary care physician (PCP) for immediate guidance. 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.titled Pilot COVID-19 At-Home Tests does not impact any of the test kits shipped. At-home test kits can be ordered through the federal government at /tests (link is. Orders for free at-home COVID-19 rapid tests on and. This product has been authorized only for the detection of proteins from SARS- CoV-2, not for any other viruses or pathogens and, These rapid antigen test kits are self-administered.This product has not been FDA cleared or approved but has been authorized by FDA under an EUA.
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