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[China]
Trade Verify
Address: Zhonghan Electronics Factory Area, Juyuan Industrial A2 Zone , Qiaotang Road Tangwei Community, Fuhai Street, Baoan District, Shenzhen
Contact name:Amy
Shenzhen Signo Group Technology Co., Ltd. |
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Verified Suppliers
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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, not for any other viruses or pathogens; and,
· 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 Clear 19 Rapid 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.
Disclaimer: If you’re currently experiencing Clear 19 Rapid symptoms, please contact your primary care physician (PCP) for immediate guidance.
iHealth® Clear 19 Rapid Antigen Rapid Test may take several days to ship. This is not a PCR test and not valid for travel. The manufacturer of the iHealth® Clear 19 Rapid Antigen Rapid Test requires test kits be stored at temperatures between 36o and 86oF (2o - 30oC). Any extended exposure of the test kit to temperatures beyond this range may affect quality of test results. 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.
The test is a 15-minute self-test to detect whether or not an individual has the Clear 19 Rapid. The test can be completed in the comfort of your own home without the need to ship your sample to a lab.
Test can be done by inserting only 1/2 to 3/4 inch with a simple non-invasive nasal swab, easy to use and zero discomfort. Step-by-step instructional videos are available in our app for easy following. (Installation of app is optional.)
The self-administered test is recommended for individuals aged 15 years and older. Adult-collection is required for testing children 2-14 years old.
iHealth has completed testing on several heat inactivated variant strains and the iHealth Clear 19 Antigen Rapid Test was able to detect the mutations.
iHealth has completed testing on several heat inactivated variant strains and the iHealth® Clear 19 Antigen Rapid Test was able to detect the mutations. The clinical performance has not been established in all circulating variants but is anticipated to be reflective of the prevalent variants in circulation at the time and location of the clinical evaluation. Performance at the time of testing may vary depending on the variants circulating, including newly emerging strains and their prevalence, which change over time.
