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Medical Devices / Submissions and Approvals

Abbott’s HBV Surface Antigen Test Earns CE Mark

Feb. 22, 2019

Abbott has been handed the CE Mark for its Determine HBsAg2 diagnostic test, a device used for detecting hepatitis B surface antigens in a patient’s blood.

The portable diagnostic test — which provides results in 15 minutes — can be used with ease in any healthcare setting and has an analytical sensitivity of 0.1 IU/ml.

Patients can provide blood, plasma or serum for the diagnostic test to determine if they are infected with the virus and require treatment.

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