iHealth™ At-Home OTC COVID-19 Test
Rapid Antigen At-Home Self Test approved for Over-The-Counter sales.
| Country of Origin | China |
| Application | Rapid Test Kit – Self Test |
| Contents | (2) Test Devices, (2) Extraction Reagent Capsules, (2) Sterile Swabs, Package Insert, Quick Reference Instruction For Use |
| Number of Tests | 2 Tests |
| Storage | Room Temperature |
| Test Format | Test Device |
| Test Method | Lateral Flow Immunochromatographic Assay |
| SKU | IH-AT-52B |
| Test Type | Rapid Antigen Detection |
| Time to Results | 15 Minute Results |
| Kit Packing | 2 Tests |
| Case Packing | 90 Kits (180 Tests) |
| Application | At-Home OTC COVID-19 Test |
| Pallet Packing | 12 cases (2,160 tests) |
- For Use Under an Emergency Use Authorization (EUA) Only: https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-authorizations-medical-devices/in-vitro-diagnostics-euas-antigen-diagnostic-tests-sars-cov-2
- The iHealth™ At-Home OTC COVID-19 Test is intended for the qualitative detection of nucleocapsid proteins from SARS-CoV-2 from individuals with or without symptoms or other epidemiological reasons to suspect COVID-19 when tested twice over two or three days with at least 24 hours and no more than 36 hours between tests
- This test is authorized for nonprescription home use with self-collected (unobserved) direct anterior nasal(NS) swab specimens from individuals aged 14 years and older or with adult-collected anterior NS samples from individuals aged 2 years or older
- Individuals should provide all results obtained with this product to their healthcare provider for public health reporting
- This product has been authorized only for the detection of proteins from SARS-CoV-2, not for any other viruses or pathogens
- The test is intended to be read at 10 minutes; If the test is read before this or is read more than 5 minutes after the indicated read time, results may be inaccurate and the test should be repeated
