iHealth COVID-19 Antigen Rapid Home Test, 2 Tests, FDA 510(k) Cleared OTC
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- # 1 At-Home COVID Test Supplier: Trusted by millions of families, with over 1 billion tests delivered nationwide through the federal government’s free COVID-19 test program during pandemic.
- FDA 510(k) Cleared 15-Minute Self-Test: The test is FDA 510(k) cleared and can be used as a 15-minute self-test to detect whether or not an individual has COVID-19. The test can be completed in the comfort of your own home without the need to ship your sample to a lab.
- Detects Multiple COVID-19 Variants: The test is designed to detect multiple COVID-19 variants, helping you stay informed even as the virus evolves.
- Easy to Use with Minimal Discomfort: The test can be done by inserting 1/2 to 3/4 inch of a simple non-invasive nasal swab. Step-by-step instructional videos are available in our app (Installation of the app is optional).
- For Ages 2 and Above: The self-administered test is recommended for individuals aged 15 years and older. Adult-collection is required for testing children 2-14 years old.
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Legal Disclaimer
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, 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.
iHealth COVID-19 Antigen Rapid Test
Product details
| Main Specification | |
|---|---|
| Manufacturer | Andon Medical Co., Ltd. |
| Brand | Ihealth |
| Product Dimensions | 3.46 x 0.71 x 0.16 inches |
| Item Weight | 0.1 ounces |
| Product information | |
| Item model number | ICO-3000 |
| Others | |
| Date First Available | 2021 or November 4 |
| Product Type | Clinical Diagnostic Test Kits |