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iHealth (2pk) - At Home COVID-19 Antigen Rapid Test
Fast, accurate, easy, and comfortable.
Use following authorized labelling for home and workplace screening.
Use following authorized labelling for home and workplace screening.
- FDA-Authorized 15 Minute Self-Test
- Designed for ease of use and minimal discomfort.
- Intended for those aged 2+ when used according to instructions.
- Show positive detection for several common COVID-19 variants tested to date.
- Group Testing Management via Mobile App
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 use with self-collected anterior nasal (nares) swab samples from individuals aged 15 years or older with symptoms of COVID-19 within the first 7 days of symptom onset. This test is also authorized for use with adult-collected nasal swab samples from individuals aged 2 years or older with symptoms of COVID-19 within the first 7 days of symptom onset.
- Test type: Antigen
- Run time: 15 minutes
- Collection type: Lower nasal swab
- Authorization: FDA EUA for home and over-the-counter use. No CLIA certification required.
- Intended Use: Lateral flow immunoassay intended for the qualitative detection of SARS-CoV-2 nucleocapsid protein.
- SARS-CoV-2: 94% Sensitivity, 98% Specificity (Self-Collected
- Specificity: No cross-reaction with species tested
- Interference: No interfering factors tested
- NDC# 56362000589
- (2) Test devices: Foil pouched test device containing one test strip which is encased in plastic device cassette with a desiccant
- (2) Extraction vials and caps
- (2) Nasal swabs: swab for anterior nasal specimen collection
- Instructions for Use
The iHealth ® COVID-19 Antigen Rapid Test is an antigen test. When COVID-19 is present in the body, your nasal secretions can also contain the SARS-CoV-2 virus (the virus that causes COVID-19). The iHealth ® COVID-19 Antigen Rapid Test is able to detect small parts of theSARS-CoV-2 virus, known as N protein or antigens, in your nasal secretions.
For asymptomatic screening, two tests over a 2-3 day interval are recommended, though please note that results might be less reliable than when used within symptoms onset.
This test is authorized for nonprescription home use with self-collected (unobserved) anterior nasal swab specimens from individuals aged 15 years and older or with adult-collected anterior nasal swab samples from individuals aged 2 years or older.
Yes. If you do not have COVID-19 symptoms, you will need to perform two tests over two or three days with at least 24 hours and no more than 48 hours between tests.
Self-Test at Home Results in 15 Mins
The iHealth COVID-19 Antigen Rapid Test provides a simple method for detecting the SARS-CoV-2 nucleocapsid protein antigen. The process requires only four steps and delivers results in 15 minutes. This test is also non-invasive, as it does not require collecting a sample from deep within the nasal cavity to ensure accuracy.
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About iHealth
Empowering Healthier Lives.
iHealth is dedicated to empowering healthier lives. As a pioneer of digital health from Silicon Valley, iHealth was founded in 2010 and launched the world's first Bluetooth-connected blood pressure monitor that worked with iOS devices. Through more than a decade of development, by integrating its FDA-approved, award-winning consumer medical devices and remote patient monitoring platform, iHealth has established a digital health ecosystem, the Unified Care model, for healthcare providers to manage chronic diseases remotely. To date, iHealth is one of the top brands in digital health & wellness and has expanded its Unified Care model to 13 states with significant clinical outcomes in hypertension and diabetes management.
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