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Title: iHealth COVID-19 Antigen Rapid Test - Shelf Life Extension (January 11, 2023) Author: FDA/CDRH Created Date: 7/3/2023 10:58:34 AM
Mar 31, 2022 · This is to notify you that your request to update the iHealth COVID-19 Antigen Rapid Test to extend the shelf-life expiration date of the iHealth COVID-19 Antigen Rapid Test to 9...
FAQ About Results and Accuracy of the iHealth COVID-19 Antigen Rapid Test. FAQ using the test. FAQ considerations for high-risk group. FAQ troubleshooting. Instructions for use and guidance. Replacement request. Efficacy. Expiration date of iHealth COVID test kit. Test interpretation.
iHealth Labs, Inc.: iHealth COVID-19 Antigen Rapid Test 9-month to 12-month self-life extension granted by the FDA July 8, 2022 Lot Number Tests with this printed expiration date (Year-month-day) Now have this extended expiration date (Year-month-day) 211CO21105 2022-05-04 2022-11-04 211CO21106 2022-05-05 2022-11-05 211CO21108 2022-05-07 2022-11-07
iHealth Labs, Inc.: iHealth COVID-19 Antigen Rapid Test 12-month to 15-month self-life extension granted by the FDA January 11, 2023. Lot Number. Tests with this printed expiration date (Year-month-day)
The iHealth® COVID-19 Antigen Rapid Test is lateral flow immunoassay device intended for the qualitative detection of nucleocapsid protein antigen from the SARS-CoV-2 virus.
The iHealth® COVID-19 Antigen Rapid Test is a lateral flow assay intended for the qualitative detection of nucleocapsid protein antigen from SARS-CoV-2. This test is authorized for non-prescription home use with self-collected anterior nasal (nares) swab samples from individuals aged 15 years or older with symptoms of COVID-19 within