Abbott’s i-STAT TBI Plasma and Alinity i TBI tests aid doctors in evaluating a suspected mild traumatic brain injury (such as a concussion) in people 18 and older within 12 hours of injury and specifically help rule out the need for a head CT scan.

FreeStyle Libre 14 Day, FreeStyle Libre 2 and FreeStyle Libre 3 systems: Failure to use FreeStyle Libre 14 day, FreeStyle Libre 2 or FreeStyle Libre 3 systems 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 for safety info.

The Libre Sense Glucose Sport biosensor is not intended for use in diagnosis, treatment or management of disease, including diabetes. Libre Sense is not available in the U.S.

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Brief Summary: Prior to using these devices, please review the Instructions for Use for a complete listing of indications, contraindications, warnings, precautions, potential adverse events and directions for use.

Indications for Use: The Assert-IQ™ ICM is indicated for the monitoring and diagnostic evaluation of patients who experience unexplained symptoms that may be cardiac-related such as: dizziness, palpitations, chest pain, syncope, and shortness of breath, as well as patients who are at risk for cardiac arrhythmias such as bradycardia, tachycardia, and sinus pauses. The Assert-IQ ICM is also indicated for patients who have been previously diagnosed with atrial fibrillation (AF) or who are susceptible to developing AF. The Assert-IQ ICM is intended to be inserted subcutaneously in the left pectoral region, also described as the left anterior chest wall. The Assert-IQ ICM has not been specifically tested for pediatric use.

Intended Use: The Assert-IQ ICM is intended to help physicians and clinicians monitor, diagnose and document the heart rhythm in patients who are susceptible to cardiac arrhythmias and unexplained symptoms by detecting arrhythmias and transmitting data for review.

Contraindications: There are no known contraindications for the insertion of the Assert-IQ ICM. However, the patient’s particular medical condition may dictate whether or not a subcutaneous, chronically inserted device can be tolerated.

Potential Adverse Events: Possible adverse events (in alphabetical order) associated with the device, include the following: allergic reaction, bleeding, chronic nerve damage, erosion, excessive fibrotic tissue growth, extrusion, formation of hematomas or cysts, infection, keloid formation and migration.

Please access the Abbott LibreSense Glucose Sport Biosensor Declarations of Conformity here.