COVID-19 Antigen Rapid Test, At Home Self-Test, 15 Minute Results
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$5,436.27
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Description
FDA authorized test is a 15-minute self-test to detect whether or not an individual has the COVID-19. The test can be completed at home without the need to ship the 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. 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 COVID-19 Antigen Rapid Test was able to detect the mutations. The iHealth Test app allows the administrator of a small group to monitor and track the group members’ test results when needed at school, work or event.
Features
- This test has been authorized by FDA under a EUA for use by authorized laboratories.
- This test has not been FDA cleared or approved.
- This test has been authorized only for the presence of IgM and IgG antibodies against SARS-CoV-2, not for any other viruses or pathogens.
- This test is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for the detection and/or diagnosis of COVID-19 under Section 564(b)(l) of the Act, 21 U.S.C. § 360bbb-3(b)(l) unless the authorization is terminated or revoked sooner.
- This product is not for home use (Emergency Use Authorization – In Vitro Diagnostic Use Only).
- Not for screening of donated blood.
Product Specifications
| Test: | RightSign COVID-19 IgG/IgM Rapid Test Cassette. |
|---|---|
| Technology: | Lateral Flow. |
| Target: | Spike. |
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