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ABOUT ABBOTT
We're on a mission. To create the technologies that once seemed like only a dream. To empower innovation by making healthcare more representative, equitable and effective. To reach the unreachable by putting access and affordability at the forefront of our products. To work with global partners to help prevent the next pandemic. To make a difference in billions of lives around the world. So you can go beyond guessing, beyond doubt, beyond the unpredictable to the truly preventable. This is HUMAN-POWERED HEALTH: ALL SYSTEMS GO
Digital Health: Rapid diagnostic tests are now household items. What will the future of at-home testing look like?
What if you could manage your diabetes from your smartphone? Now you can with FreeStyle Libre 3, our next-generation continuous glucose monitoring system.
The world’s only leadless pacemaker designed to be retrievable, with a unique mapping capability to assess the correct placement of the device before final implantation.
The leading remote monitoring platform for people living with heart failure clinically proven to help physicians prevent worsening heart failure, lower mortality rates and improve quality of life.
BinaxNOW is helping people quickly detect COVID-19 from the comfort of their home.
In response to the urgent health need, our scientists developed a monkeypox (now referred to as Mpox) PCR Test for use on the Alinity m laboratory instrument.
The first-of-its-kind rapid test on a portable instrument for traumatic brain injury (TBI).
Using a device similar to a pacemaker, it sends targeted electrical signals to the areas of the brain that aren’t working properly, giving people with Parkinson’s disease the ability to “tune out” tremor and restore control.
Indications and Important Safety Information
Failure to use FreeStyle Libre 3 system as instructed in labeling may result in missing a severe low or high glucose event and/or making a treatment decision, resulting in injury. If glucose alarms and readings do not match symptoms or expectations, use a fingerstick value from a blood glucose meter for treatment decisions. Seek medical attention when appropriate or contact Abbott at 855-632-8658 or FreeStyleLibre.us safety info.
The Lingo portfolio of products are under development and are not intended for medical use. They are not intended for use in screening, diagnosis, treatment, cure, mitigation, prevention, or monitoring of diseases, including diabetes. The products are not for sale in the U.S.
Emergency Use Authorizations
BinaxNOW COVID-19 test: The BinaxNOW COVID-19 tests have not been FDA cleared or approved. They have been authorized by the FDA under an emergency use authorization. They have been authorized only for the detection of proteins from SARS-CoV-2, not for any other viruses or pathogens, and are 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. § 360bbb-3(b)(1), unless the declaration is terminated or authorization is revoked sooner.
Alinity m Monkeypox PCR test: This product has not been FDA cleared or approved, but has been authorized for emergency use by FDA under an EUA for use by the authorized laboratories; This product has been authorized only for the detection of nucleic acid from monkeypox virus, 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 infection with the monkeypox virus, including in vitro diagnostics that detect and/or diagnose infection with non-variola Orthopoxvirus, 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.
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