iHealth COVID-19 + Flu A&B 3-in-1 Rapid Self-Test
2 ct box
Warnings
For use under Emergency Use Authorization (EUA) only. Do not use if you have had symptoms longer than 4 days or no symptoms at all.
Details
Rapid self test. Results in 15 mins. The iHealth Covid-19/Flu A&B Rapid Test is a lateral flow immunoassay intended for the qualitative detection and differentiation of SARS-CoV-2, influenza A, and influenza B protein antigens. This test is authorized for non-prescription home use with self-collected anterior nares nasal swab specimens from individuals aged 14 years or older, or with adult-collected anterior nasal swab specimens from individuals two (2) years or older. In the USA, this product has not been FDA cleared or approved, but has been authorized by FDA under an Emergency Use Authorization (EUA). This product has been authorized only for the detection of proteins from SARS-CoV-2, influenza A, and influenza B, not for any other viruses or pathogens. 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.5360bbb-3(b)(1), unless the declaration is terminated or authorization is revoked sooner. Persons with risk factors for severe disease from respiratory pathogens should consult and follow-up with a healthcare provider. Determining a negative result requires multiple tests. You may need to purchase additional tests to perform serial (repeat) testing. This test is more likely to give you a false negative result when you have Covid-19 than a lab-based molecular test. Items necessary to use the test but not provided in the test kit: timer or clock. Contents: 2 x Covid-19/Flu A&B Test Card; 2 x Tube; 2 x Swab. Components: Covid-19/Flu A&B Test Card. Tube. Swab. For more information about current expiration dates for at-home OTC Covid-19/influenza diagnostic tests, please visit: http://www/fda/gov/covid-test.
Insert tube. Use immediately after opening the foil pouch. Avoid contact of the extraction solution in the Test Tube with skin and eyes. Store between 36 degrees F - 86 degrees F (2 degrees C - 30 degrees C).
Country of Origin
China
Manufacturer
IHealth Labs, Inc.