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Home » Abbott Earns FDA OK for Handheld Concussion Blood Test
Abbott Earns FDA OK for Handheld Concussion Blood Test
January 12, 2021
Abbott Laboratories has received the FDA’s 510(k) marketing clearance for a test that helps evaluate mild traumatic brain injuries, also known as concussions, using a handheld device.
The blood test is run on the company’s handheld i-STAT Alinity device, producing a result within 15 minutes after the patient’s blood plasma sample is inserted.
The diagnostic assesses plasma samples for biomarkers UCH-L1 and GFAP, two proteins that are seen after a concussion or head trauma.
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