IHealth Rapid Antigen Swab Test Nasal Specimen FDA For Public Area

Independently-sealed packaging
ensures safe and hygienic testing.

The swabs and test cards of iHealth Rapid Antigen Swab Test are sealed and independently packaged to ensure the safety and hygiene of the product.

• This product has not been FDA cleared or approved; but has been authorized by FDA under an EUA;
• This product has been authorized only for the detection of proteins from Cov 2 Antigen Test, 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 Rapid Antigen Swab Test under Section 564(b)(1) of the Federal Food, Drug and Cosmetic Act, 21 U.S.C. § 360bbb-3(b)(1), unless the declaration is terminated or authorization is revoked sooner.

Disclaimer: If you’re currently experiencing Rapid Antigen Swab Test symptoms, please contact your primary care physician (PCP) for immediate guidance.
iHealth® Rapid Antigen Swab Test Antigen Rapid Test may take several days to ship. This is not a PCR test and not valid for travel. The manufacturer of the iHealth® Rapid Antigen Swab Test requires test kits be stored at temperatures between 2℃ - 30℃). Any extended exposure of the test kit to temperatures beyond this range may affect quality of test results. If you have ordered home delivery of the test kit and expect temperatures in your area to be outside of this range at time of delivery, it is recommended that you arrange for someone to be home at or near time of delivery to receive the test kit.

Founded in 2011, Signo is a high-tech enterprise specializing in the development, production and sales of in vitro diagnostic reagents.
The company has established a strict quality management system and passed ISO9001: 2015 and ISO13485: 2016 international quality system certifications.

It has advanced international fully automatic production equipment, and the workshop is designed in strict accordance with standards and has reached 10,000-level purification standards. Signo has strong biotechnology power, and currently has more than 60 independent intellectual property rights, including 2 invention patents, and undertakes many provincial and municipal science and technology innovation projects.The products are mainly related to microorganisms / clinical reagents, medical equipment / robots, biochemical diagnostic reagents and so on. Signo's corporate purpose is to care for human health, develop a magnificent career in medical technology, and achieve a successful life. Guided by the ingenious product concept of pursuing perfection, the company is committed to providing disposable medical microbial culture media.The company continuously improves technology and develops new products according to market needs, and makes every effort to meet customer needs.