iHealth iHealth COVID-19 + Flu A&B 3-in-1 Rapid Self-Test
Product Information
Ingredients
No ingredients available.
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.
Directions
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.
Product Disclaimer:
Hannaford is committed to providing accurate nutritional information to its customers. As an important part of that effort we voluntarily provide such material on our website. We rely upon our suppliers to provide us with this information on an ongoing basis and to advise us immediately whenever any new claims or adjustments to declared values are made, so that we can properly maintain the accuracy of this online resource. We have, however, experienced occasional situations in the past where, due to the lack of such notice or for some other reason, minor discrepancies in this area have occurred. We therefore strongly encourage our customers to read the labels of any of the products that they purchase in order to make certain that they are compatible with their own nutritional preferences and expectations. If you receive a product from Hannaford, and the nutritional information on the product label does not match the information on our site, please contact Hannaford customer service and we will arrange for a credit to issue for the product at issue.