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Medical Devices / Submissions and Approvals

Abbott Gains CE Mark for Diagnostics System and Assays

March 20, 2019
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Abbott earned the CE Mark for its Alinity M diagnostics system and assays designed to test patients for infectious and sexually transmitted diseases.

The device comes with assays that cover virologic testing for hepatitis B and C viruses and HIV-1, as well as STDs like HPV, chlamydia, gonorrhea, trichomoniasis and mycoplasma genitalium.

The Alinity M is designed to save laboratory space and time spent learning and maintaining instruments by performing the functions of several devices.

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